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Flu study shows overall efficacy of LAIV, but weakness for one strain
Trivalent and quadrivalent inactivated influenza vaccine (IIV) and quadrivalent live attenuated influenza vaccine (LAIV) all gave statistically significant protection against any flu in U.S. children aged 2-17 years in 2015-2016, Katherine A. Poehling, MD, of Wake Forest University, Winston-Salem, N.C., and her associates reported in a study of more than 1,000 children.
“This study also adds to the clinical evidence suggesting that ,” the researchers concluded.
“The 2015-2016 season northern hemisphere trivalent IIV included A/California/7/2009 (H1N1)-like virus, a new A/Switzerland/9715293/2013 (H3N2)-like virus, and a new B/Phuket/3073/2013-like virus (Yamagata lineage),” the investigators noted. “Quadrivalent IIV was similar to trivalent IIV and also included B/Brisbane/60/2008-like virus (Victoria lineage). LAIV was similar to quadrivalent IIV, except that it contained A/Bolivia/559/2013.”
Of the 1,012 children enrolled, 59% were unvaccinated, 10% were given LAIV, 10% received trivalent IIV, 20% were given quadrivalent IIV, and 1% received IIV of “unknown valence.”
Vaccine efficacy against any influenza was 46% for LAIV and 65% for IIV, compared with no vaccination. But only IIV gave “significant protection against influenza A(H1N1)pdm09 strains in the total study population,” Dr. Poehling and her associates said. Vaccine efficacy against influenza A(H1N1)pdm09 strains was 50% for LAIV and 71% for IIV.
Read more in Clinical Infectious Diseases (2017 Oct 4. doi: 10.1093/cid/cix869).
Trivalent and quadrivalent inactivated influenza vaccine (IIV) and quadrivalent live attenuated influenza vaccine (LAIV) all gave statistically significant protection against any flu in U.S. children aged 2-17 years in 2015-2016, Katherine A. Poehling, MD, of Wake Forest University, Winston-Salem, N.C., and her associates reported in a study of more than 1,000 children.
“This study also adds to the clinical evidence suggesting that ,” the researchers concluded.
“The 2015-2016 season northern hemisphere trivalent IIV included A/California/7/2009 (H1N1)-like virus, a new A/Switzerland/9715293/2013 (H3N2)-like virus, and a new B/Phuket/3073/2013-like virus (Yamagata lineage),” the investigators noted. “Quadrivalent IIV was similar to trivalent IIV and also included B/Brisbane/60/2008-like virus (Victoria lineage). LAIV was similar to quadrivalent IIV, except that it contained A/Bolivia/559/2013.”
Of the 1,012 children enrolled, 59% were unvaccinated, 10% were given LAIV, 10% received trivalent IIV, 20% were given quadrivalent IIV, and 1% received IIV of “unknown valence.”
Vaccine efficacy against any influenza was 46% for LAIV and 65% for IIV, compared with no vaccination. But only IIV gave “significant protection against influenza A(H1N1)pdm09 strains in the total study population,” Dr. Poehling and her associates said. Vaccine efficacy against influenza A(H1N1)pdm09 strains was 50% for LAIV and 71% for IIV.
Read more in Clinical Infectious Diseases (2017 Oct 4. doi: 10.1093/cid/cix869).
Trivalent and quadrivalent inactivated influenza vaccine (IIV) and quadrivalent live attenuated influenza vaccine (LAIV) all gave statistically significant protection against any flu in U.S. children aged 2-17 years in 2015-2016, Katherine A. Poehling, MD, of Wake Forest University, Winston-Salem, N.C., and her associates reported in a study of more than 1,000 children.
“This study also adds to the clinical evidence suggesting that ,” the researchers concluded.
“The 2015-2016 season northern hemisphere trivalent IIV included A/California/7/2009 (H1N1)-like virus, a new A/Switzerland/9715293/2013 (H3N2)-like virus, and a new B/Phuket/3073/2013-like virus (Yamagata lineage),” the investigators noted. “Quadrivalent IIV was similar to trivalent IIV and also included B/Brisbane/60/2008-like virus (Victoria lineage). LAIV was similar to quadrivalent IIV, except that it contained A/Bolivia/559/2013.”
Of the 1,012 children enrolled, 59% were unvaccinated, 10% were given LAIV, 10% received trivalent IIV, 20% were given quadrivalent IIV, and 1% received IIV of “unknown valence.”
Vaccine efficacy against any influenza was 46% for LAIV and 65% for IIV, compared with no vaccination. But only IIV gave “significant protection against influenza A(H1N1)pdm09 strains in the total study population,” Dr. Poehling and her associates said. Vaccine efficacy against influenza A(H1N1)pdm09 strains was 50% for LAIV and 71% for IIV.
Read more in Clinical Infectious Diseases (2017 Oct 4. doi: 10.1093/cid/cix869).
FROM CLINICAL INFECTIOUS DISEASES
Adverse effects low in long-term crisaborole eczema study
, suggesting that the therapy has the potential to treat atopic dermatitis without the side effects of the current topical treatments, said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital, San Diego, and his associates.
The multicenter, long-term, open-label safety study of 48 weeks assessed 517 patients with mild to moderate atopic dermatitis after they had finished a 28-day phase 3 study of 2% crisaborole ointment. The patients in the extension study were told to apply crisaborole twice daily for 28 days, with an off-treatment period initiated if their disease severity was clear or almost clear after the 28 days. They were told to stop the treatment if they had no improvement in their Investigator’s Static Global Assessment score after three consecutive treatment periods.
Treatment-related adverse events occurred in 10% of patients; 86% of them were mild or moderate. Dermatitis atopic – defined as worsening, exacerbation, flare, or flare-up – occurred in 3% of patients; application-site burning or stinging in 2%; and application-site infection in 1%. The median duration was 18 days for dermatitis atopic, 5 days for application-site burning or stinging, and 12 days for application-site infection. The frequency of these adverse events did not increase over time, the investigators said.
Most patients (78%) did not need rescue therapy, 79% later resumed crisaborole therapy at a later date, and 76% stayed in the study until week 48 or the end of the study.
Read more in the Journal of the American Academy of Dermatology (2017 Oct;77[4]:641-9).
, suggesting that the therapy has the potential to treat atopic dermatitis without the side effects of the current topical treatments, said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital, San Diego, and his associates.
The multicenter, long-term, open-label safety study of 48 weeks assessed 517 patients with mild to moderate atopic dermatitis after they had finished a 28-day phase 3 study of 2% crisaborole ointment. The patients in the extension study were told to apply crisaborole twice daily for 28 days, with an off-treatment period initiated if their disease severity was clear or almost clear after the 28 days. They were told to stop the treatment if they had no improvement in their Investigator’s Static Global Assessment score after three consecutive treatment periods.
Treatment-related adverse events occurred in 10% of patients; 86% of them were mild or moderate. Dermatitis atopic – defined as worsening, exacerbation, flare, or flare-up – occurred in 3% of patients; application-site burning or stinging in 2%; and application-site infection in 1%. The median duration was 18 days for dermatitis atopic, 5 days for application-site burning or stinging, and 12 days for application-site infection. The frequency of these adverse events did not increase over time, the investigators said.
Most patients (78%) did not need rescue therapy, 79% later resumed crisaborole therapy at a later date, and 76% stayed in the study until week 48 or the end of the study.
Read more in the Journal of the American Academy of Dermatology (2017 Oct;77[4]:641-9).
, suggesting that the therapy has the potential to treat atopic dermatitis without the side effects of the current topical treatments, said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital, San Diego, and his associates.
The multicenter, long-term, open-label safety study of 48 weeks assessed 517 patients with mild to moderate atopic dermatitis after they had finished a 28-day phase 3 study of 2% crisaborole ointment. The patients in the extension study were told to apply crisaborole twice daily for 28 days, with an off-treatment period initiated if their disease severity was clear or almost clear after the 28 days. They were told to stop the treatment if they had no improvement in their Investigator’s Static Global Assessment score after three consecutive treatment periods.
Treatment-related adverse events occurred in 10% of patients; 86% of them were mild or moderate. Dermatitis atopic – defined as worsening, exacerbation, flare, or flare-up – occurred in 3% of patients; application-site burning or stinging in 2%; and application-site infection in 1%. The median duration was 18 days for dermatitis atopic, 5 days for application-site burning or stinging, and 12 days for application-site infection. The frequency of these adverse events did not increase over time, the investigators said.
Most patients (78%) did not need rescue therapy, 79% later resumed crisaborole therapy at a later date, and 76% stayed in the study until week 48 or the end of the study.
Read more in the Journal of the American Academy of Dermatology (2017 Oct;77[4]:641-9).
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Vaccination program cut hospital-treated RV gastroenteritis in young children
under 5 years, and it more than adequately pays for itself in secondary health care costs, said Tuija Leino of the National Institute for Health and Welfare, Helsinki, and associates.
Since 2009, all Finnish children younger than 5 years have been offered an RV vaccine.
The investigators conducted a register-based study comparing the RV disease burden before and after introduction of RV vaccination, with the years 1999-2005 as the prevaccine period and the years 2010-2014 as the vaccination period. The study population was all children younger than 5 years living in Finland during the two study periods.
The relative reduction in inpatient RVGE incidence ranged from 86% in the 4-year-old children to 94% in the 0-year-old children, the researchers reported. That amounted to 843 prevented inpatient cases in children under 5 years.
The highest incidence of RVGE, which is rarely treated in hospital outpatients, was 0.4/1,000 person-years in children aged 1 year or younger. The relative reduction in outpatient RVGE incidence was 86% in the 0-year-olds and 100% in the 3- and 4-year-olds. The RV vaccination program prevented only 64 hospital outpatient cases in children younger than 5 years of age in 2014.
RV vaccination also resulted in a reduction of unspecified viral gastroenteritis (UVGE) incidence by 84%. Because the incidence of UVGE in 1-year-olds during the prevaccine era was more than twice the incidence of RVGE, the absolute reduction from 10.7 to 1.7 per 1,000 person-years “reflects a removal of a much larger disease burden than the reduction in the most specific outcome of inpatient RVGE,” the researchers said.
The annually prevented inpatient UVGE cases in children up to 4 years was 1,522, almost twice as many as the prevented inpatient RVGE cases. In the prevaccine era, the UVGE reduction was greatest among 1-year-olds, at 71%. In children younger than 5 years of age, 1,313 UVGE hospital outpatient cases were prevented in 2014.
“Considering secondary health care, the program annually pays for itself almost two times over in Finland,” the investigators concluded.
Read more in Vaccine (2017 Oct 9;35[42]:5611-7).
The researchers had no conflicts of interest.
cnellist@frontlinmedcom.com
under 5 years, and it more than adequately pays for itself in secondary health care costs, said Tuija Leino of the National Institute for Health and Welfare, Helsinki, and associates.
Since 2009, all Finnish children younger than 5 years have been offered an RV vaccine.
The investigators conducted a register-based study comparing the RV disease burden before and after introduction of RV vaccination, with the years 1999-2005 as the prevaccine period and the years 2010-2014 as the vaccination period. The study population was all children younger than 5 years living in Finland during the two study periods.
The relative reduction in inpatient RVGE incidence ranged from 86% in the 4-year-old children to 94% in the 0-year-old children, the researchers reported. That amounted to 843 prevented inpatient cases in children under 5 years.
The highest incidence of RVGE, which is rarely treated in hospital outpatients, was 0.4/1,000 person-years in children aged 1 year or younger. The relative reduction in outpatient RVGE incidence was 86% in the 0-year-olds and 100% in the 3- and 4-year-olds. The RV vaccination program prevented only 64 hospital outpatient cases in children younger than 5 years of age in 2014.
RV vaccination also resulted in a reduction of unspecified viral gastroenteritis (UVGE) incidence by 84%. Because the incidence of UVGE in 1-year-olds during the prevaccine era was more than twice the incidence of RVGE, the absolute reduction from 10.7 to 1.7 per 1,000 person-years “reflects a removal of a much larger disease burden than the reduction in the most specific outcome of inpatient RVGE,” the researchers said.
The annually prevented inpatient UVGE cases in children up to 4 years was 1,522, almost twice as many as the prevented inpatient RVGE cases. In the prevaccine era, the UVGE reduction was greatest among 1-year-olds, at 71%. In children younger than 5 years of age, 1,313 UVGE hospital outpatient cases were prevented in 2014.
“Considering secondary health care, the program annually pays for itself almost two times over in Finland,” the investigators concluded.
Read more in Vaccine (2017 Oct 9;35[42]:5611-7).
The researchers had no conflicts of interest.
cnellist@frontlinmedcom.com
under 5 years, and it more than adequately pays for itself in secondary health care costs, said Tuija Leino of the National Institute for Health and Welfare, Helsinki, and associates.
Since 2009, all Finnish children younger than 5 years have been offered an RV vaccine.
The investigators conducted a register-based study comparing the RV disease burden before and after introduction of RV vaccination, with the years 1999-2005 as the prevaccine period and the years 2010-2014 as the vaccination period. The study population was all children younger than 5 years living in Finland during the two study periods.
The relative reduction in inpatient RVGE incidence ranged from 86% in the 4-year-old children to 94% in the 0-year-old children, the researchers reported. That amounted to 843 prevented inpatient cases in children under 5 years.
The highest incidence of RVGE, which is rarely treated in hospital outpatients, was 0.4/1,000 person-years in children aged 1 year or younger. The relative reduction in outpatient RVGE incidence was 86% in the 0-year-olds and 100% in the 3- and 4-year-olds. The RV vaccination program prevented only 64 hospital outpatient cases in children younger than 5 years of age in 2014.
RV vaccination also resulted in a reduction of unspecified viral gastroenteritis (UVGE) incidence by 84%. Because the incidence of UVGE in 1-year-olds during the prevaccine era was more than twice the incidence of RVGE, the absolute reduction from 10.7 to 1.7 per 1,000 person-years “reflects a removal of a much larger disease burden than the reduction in the most specific outcome of inpatient RVGE,” the researchers said.
The annually prevented inpatient UVGE cases in children up to 4 years was 1,522, almost twice as many as the prevented inpatient RVGE cases. In the prevaccine era, the UVGE reduction was greatest among 1-year-olds, at 71%. In children younger than 5 years of age, 1,313 UVGE hospital outpatient cases were prevented in 2014.
“Considering secondary health care, the program annually pays for itself almost two times over in Finland,” the investigators concluded.
Read more in Vaccine (2017 Oct 9;35[42]:5611-7).
The researchers had no conflicts of interest.
cnellist@frontlinmedcom.com
from vaccine
Maternally derived pneumococcal, meningococcal antibodies may affect vaccine effectiveness
, according to a new study.
That information may be useful in deciding the impact of vaccination programs that use a combination of maternal and infant vaccines and consider schedules with a delayed start, said Merryn Voysey of the University of Oxford (England) and her associates.
In this study, 5,097 children in 16 cohorts from 13 countries had pneumococcal antibody concentrations assessed from blood samples taken before their first dose of vaccine, and 2,925 infants from 5 cohorts in 4 countries had meningococcal antibody concentrations available.
At the time of their first vaccination, the children were ages 5-23 weeks and were from countries in Europe, Africa, Latin America, and South and East Asia. These populations have no routine programs of immunization in pregnancy, the researchers said. So, the maternal antibodies are passively acquired, and the decay rates may differ from those induced by maternal vaccinations.
The seroprevalence of maternal antibodies in infants was 92% for pneumococcal serotype 14 and 80% for serotype 19F; it was 30% for serotype 4 and 34% for serotype 1. Thirteen percent of infants had detectable levels of group C meningococcal antibodies prior to vaccination, and 43% had group A antibodies.
For the pneumococcal antibodies, “there was statistically significant variation in half-life estimates between country cohorts and between serotypes (both P less than .0001),” the researchers said. The half-life estimate was lowest – at 39 days – for serotype 6B, and highest – at 48 days – for serotype 5. The overall estimate across serotypes was 43 days.
“The age of the child was not significantly associated with decay rates (P = .103), confirming the assumption of exponential decay,” they said.
For the meningococcal antibodies, the half-lives were 43 days for group A and 40 days for group C.
“Substantial proportions of infants have antibodies to many vaccine serotypes of pneumococcus at the age when a vaccine program might normally commence,” the investigators noted. “Conversely, antibodies against capsular groups A and C meningococcal polysaccharides were less common, particularly for group C, which was only present in 13% of infants in the four countries contained in this analysis.
“Higher levels of group A meningococcal antibodies than group C have also been seen in unvaccinated adults of childbearing age in the Netherlands, and in mothers in the United Kingdom,” the researchers added. “Passively acquired maternal antibody has been shown to adversely affect the magnitude of the immune response to vaccination with pneumococcal conjugate vaccine, and increase the occurrence of otitis media in infants under 6 months of age.”
The proportion of infants who had maternal antipneumococcal antibodies differed between serotypes, the authors noted. Almost all infants had serotype 14 pneumococcal antibodies, and very high proportions of infants had serotype 19F antibodies.
“We have previously shown that the antibody response to vaccination with pneumococcal conjugate vaccine is adversely affected by the presence of maternal antibody,” the investigators said. “This inhibitory effect is greatest for serotype 14, with children seropositive from maternal antibodies having a response to vaccination that is only three-quarters the magnitude of those with no maternal antibody.”
Read more in Vaccine (2017 Oct 13;35[43]:5850-7).
, according to a new study.
That information may be useful in deciding the impact of vaccination programs that use a combination of maternal and infant vaccines and consider schedules with a delayed start, said Merryn Voysey of the University of Oxford (England) and her associates.
In this study, 5,097 children in 16 cohorts from 13 countries had pneumococcal antibody concentrations assessed from blood samples taken before their first dose of vaccine, and 2,925 infants from 5 cohorts in 4 countries had meningococcal antibody concentrations available.
At the time of their first vaccination, the children were ages 5-23 weeks and were from countries in Europe, Africa, Latin America, and South and East Asia. These populations have no routine programs of immunization in pregnancy, the researchers said. So, the maternal antibodies are passively acquired, and the decay rates may differ from those induced by maternal vaccinations.
The seroprevalence of maternal antibodies in infants was 92% for pneumococcal serotype 14 and 80% for serotype 19F; it was 30% for serotype 4 and 34% for serotype 1. Thirteen percent of infants had detectable levels of group C meningococcal antibodies prior to vaccination, and 43% had group A antibodies.
For the pneumococcal antibodies, “there was statistically significant variation in half-life estimates between country cohorts and between serotypes (both P less than .0001),” the researchers said. The half-life estimate was lowest – at 39 days – for serotype 6B, and highest – at 48 days – for serotype 5. The overall estimate across serotypes was 43 days.
“The age of the child was not significantly associated with decay rates (P = .103), confirming the assumption of exponential decay,” they said.
For the meningococcal antibodies, the half-lives were 43 days for group A and 40 days for group C.
“Substantial proportions of infants have antibodies to many vaccine serotypes of pneumococcus at the age when a vaccine program might normally commence,” the investigators noted. “Conversely, antibodies against capsular groups A and C meningococcal polysaccharides were less common, particularly for group C, which was only present in 13% of infants in the four countries contained in this analysis.
“Higher levels of group A meningococcal antibodies than group C have also been seen in unvaccinated adults of childbearing age in the Netherlands, and in mothers in the United Kingdom,” the researchers added. “Passively acquired maternal antibody has been shown to adversely affect the magnitude of the immune response to vaccination with pneumococcal conjugate vaccine, and increase the occurrence of otitis media in infants under 6 months of age.”
The proportion of infants who had maternal antipneumococcal antibodies differed between serotypes, the authors noted. Almost all infants had serotype 14 pneumococcal antibodies, and very high proportions of infants had serotype 19F antibodies.
“We have previously shown that the antibody response to vaccination with pneumococcal conjugate vaccine is adversely affected by the presence of maternal antibody,” the investigators said. “This inhibitory effect is greatest for serotype 14, with children seropositive from maternal antibodies having a response to vaccination that is only three-quarters the magnitude of those with no maternal antibody.”
Read more in Vaccine (2017 Oct 13;35[43]:5850-7).
, according to a new study.
That information may be useful in deciding the impact of vaccination programs that use a combination of maternal and infant vaccines and consider schedules with a delayed start, said Merryn Voysey of the University of Oxford (England) and her associates.
In this study, 5,097 children in 16 cohorts from 13 countries had pneumococcal antibody concentrations assessed from blood samples taken before their first dose of vaccine, and 2,925 infants from 5 cohorts in 4 countries had meningococcal antibody concentrations available.
At the time of their first vaccination, the children were ages 5-23 weeks and were from countries in Europe, Africa, Latin America, and South and East Asia. These populations have no routine programs of immunization in pregnancy, the researchers said. So, the maternal antibodies are passively acquired, and the decay rates may differ from those induced by maternal vaccinations.
The seroprevalence of maternal antibodies in infants was 92% for pneumococcal serotype 14 and 80% for serotype 19F; it was 30% for serotype 4 and 34% for serotype 1. Thirteen percent of infants had detectable levels of group C meningococcal antibodies prior to vaccination, and 43% had group A antibodies.
For the pneumococcal antibodies, “there was statistically significant variation in half-life estimates between country cohorts and between serotypes (both P less than .0001),” the researchers said. The half-life estimate was lowest – at 39 days – for serotype 6B, and highest – at 48 days – for serotype 5. The overall estimate across serotypes was 43 days.
“The age of the child was not significantly associated with decay rates (P = .103), confirming the assumption of exponential decay,” they said.
For the meningococcal antibodies, the half-lives were 43 days for group A and 40 days for group C.
“Substantial proportions of infants have antibodies to many vaccine serotypes of pneumococcus at the age when a vaccine program might normally commence,” the investigators noted. “Conversely, antibodies against capsular groups A and C meningococcal polysaccharides were less common, particularly for group C, which was only present in 13% of infants in the four countries contained in this analysis.
“Higher levels of group A meningococcal antibodies than group C have also been seen in unvaccinated adults of childbearing age in the Netherlands, and in mothers in the United Kingdom,” the researchers added. “Passively acquired maternal antibody has been shown to adversely affect the magnitude of the immune response to vaccination with pneumococcal conjugate vaccine, and increase the occurrence of otitis media in infants under 6 months of age.”
The proportion of infants who had maternal antipneumococcal antibodies differed between serotypes, the authors noted. Almost all infants had serotype 14 pneumococcal antibodies, and very high proportions of infants had serotype 19F antibodies.
“We have previously shown that the antibody response to vaccination with pneumococcal conjugate vaccine is adversely affected by the presence of maternal antibody,” the investigators said. “This inhibitory effect is greatest for serotype 14, with children seropositive from maternal antibodies having a response to vaccination that is only three-quarters the magnitude of those with no maternal antibody.”
Read more in Vaccine (2017 Oct 13;35[43]:5850-7).
FROM VACCINE
Guidelines cut acute chest syndrome hospital returns in pediatric sickle cell
Children with sickle cell disease who experience acute chest syndrome benefit from the current guideline-recommended antibiotic regimen, based on data from more than 7,000 patients.
Although acute chest syndrome (ACS) is among the most common complications of sickle cell disease (SCD), data on the effectiveness of the recommended antibiotic therapies (macrolides and cephalosporins) are lacking, wrote David G. Bundy, MD, of the Medical University of South Carolina, Charleston, and colleagues. ACS often leads to intensive hospital care and 1%-2% morbidity, they noted.
The most recent guidelines from the National Heart, Lung, and Blood Institute call for “an intravenous cephalosporin and an oral macrolide antibiotic,” the researchers said.
To determine the impact of antibiotic use as directed on reducing hospital readmissions in young SCD patients, the researchers reviewed data from 14,480 hospitalizations for ACS involving 7,178 children and young adults aged 0-22 years seen at 41 hospitals in the United States (JAMA Pediatr. 2017 Sep 11. doi: 10.1001/jamapediatrics.2017.2526).
“This high level of interhospital variation also suggests possible clinician disagreement regarding the ideal antibiotic treatment for children with ACS,” the researchers wrote.
Rates of all-cause readmission and 30-day ACS-related readmission were significantly lower among patients who received the recommended antibiotics (odds ratio, 0.50 and 0.71, respectively). Children aged 5-9 years were most likely to receive the recommended antibiotics (80%), while young adults aged 19-22 years were the least likely (64%).
The findings were limited by several factors, including coding errors and incomplete clinical information, the researchers noted. But the results suggest that the guideline-recommended antibiotics are effective, “so more robust dissemination and implementation of existing treatment guidelines may reduce readmissions in this high-risk population,” they said.
The researchers had no financial conflicts to disclose. Study coauthor Staci Arnold, MD, was supported in part by the Robert Wood Johnson Foundation Harold Amos Medical Faculty Development Program.
Children with sickle cell disease who experience acute chest syndrome benefit from the current guideline-recommended antibiotic regimen, based on data from more than 7,000 patients.
Although acute chest syndrome (ACS) is among the most common complications of sickle cell disease (SCD), data on the effectiveness of the recommended antibiotic therapies (macrolides and cephalosporins) are lacking, wrote David G. Bundy, MD, of the Medical University of South Carolina, Charleston, and colleagues. ACS often leads to intensive hospital care and 1%-2% morbidity, they noted.
The most recent guidelines from the National Heart, Lung, and Blood Institute call for “an intravenous cephalosporin and an oral macrolide antibiotic,” the researchers said.
To determine the impact of antibiotic use as directed on reducing hospital readmissions in young SCD patients, the researchers reviewed data from 14,480 hospitalizations for ACS involving 7,178 children and young adults aged 0-22 years seen at 41 hospitals in the United States (JAMA Pediatr. 2017 Sep 11. doi: 10.1001/jamapediatrics.2017.2526).
“This high level of interhospital variation also suggests possible clinician disagreement regarding the ideal antibiotic treatment for children with ACS,” the researchers wrote.
Rates of all-cause readmission and 30-day ACS-related readmission were significantly lower among patients who received the recommended antibiotics (odds ratio, 0.50 and 0.71, respectively). Children aged 5-9 years were most likely to receive the recommended antibiotics (80%), while young adults aged 19-22 years were the least likely (64%).
The findings were limited by several factors, including coding errors and incomplete clinical information, the researchers noted. But the results suggest that the guideline-recommended antibiotics are effective, “so more robust dissemination and implementation of existing treatment guidelines may reduce readmissions in this high-risk population,” they said.
The researchers had no financial conflicts to disclose. Study coauthor Staci Arnold, MD, was supported in part by the Robert Wood Johnson Foundation Harold Amos Medical Faculty Development Program.
Children with sickle cell disease who experience acute chest syndrome benefit from the current guideline-recommended antibiotic regimen, based on data from more than 7,000 patients.
Although acute chest syndrome (ACS) is among the most common complications of sickle cell disease (SCD), data on the effectiveness of the recommended antibiotic therapies (macrolides and cephalosporins) are lacking, wrote David G. Bundy, MD, of the Medical University of South Carolina, Charleston, and colleagues. ACS often leads to intensive hospital care and 1%-2% morbidity, they noted.
The most recent guidelines from the National Heart, Lung, and Blood Institute call for “an intravenous cephalosporin and an oral macrolide antibiotic,” the researchers said.
To determine the impact of antibiotic use as directed on reducing hospital readmissions in young SCD patients, the researchers reviewed data from 14,480 hospitalizations for ACS involving 7,178 children and young adults aged 0-22 years seen at 41 hospitals in the United States (JAMA Pediatr. 2017 Sep 11. doi: 10.1001/jamapediatrics.2017.2526).
“This high level of interhospital variation also suggests possible clinician disagreement regarding the ideal antibiotic treatment for children with ACS,” the researchers wrote.
Rates of all-cause readmission and 30-day ACS-related readmission were significantly lower among patients who received the recommended antibiotics (odds ratio, 0.50 and 0.71, respectively). Children aged 5-9 years were most likely to receive the recommended antibiotics (80%), while young adults aged 19-22 years were the least likely (64%).
The findings were limited by several factors, including coding errors and incomplete clinical information, the researchers noted. But the results suggest that the guideline-recommended antibiotics are effective, “so more robust dissemination and implementation of existing treatment guidelines may reduce readmissions in this high-risk population,” they said.
The researchers had no financial conflicts to disclose. Study coauthor Staci Arnold, MD, was supported in part by the Robert Wood Johnson Foundation Harold Amos Medical Faculty Development Program.
FROM JAMA PEDIATRICS
Key clinical point: Treatment with the recommended antibiotics was effective in reducing hospital readmissions for acute chest syndrome in children and young adults up to age 22 years with sickle cell disease.
Major finding: Hospital readmission for 30-day acute chest syndrome and all-cause readmission were significantly lower (odds ratio, 0.71 and 0.50, respectively) among children with sickle cell disease who received antibiotics (macrolides and cephalosporins) according to current guidelines, compared with those who did not.
Data source: A retrospective, multicenter study of 14,480 hospitalizations at 41 locations involving 7,178 children and young adults aged 0-22 years.
Disclosures: The researchers had no financial conflicts to disclose. Study coauthor Staci Arnold, MD, was supported in part by the Robert Wood Johnson Foundation Harold Amos Medical Faculty Development Program.
Sorting out syncope signs and symptoms in kids remains essential
CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.
“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “,” which is defined as transient loss of consciousness.
“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”
Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”
Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”
Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*
“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”
Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
Refer to a pediatric cardiologist
For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”
Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
Ruling out a cardiac cause
The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.
“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”
Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”
Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.
A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.
The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”
‘The world’s most boring test’
For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”
“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”
Dr. Deal had no relevant financial disclosures.
*This article was updated on 10/25/2017.
CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.
“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “,” which is defined as transient loss of consciousness.
“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”
Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”
Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”
Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*
“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”
Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
Refer to a pediatric cardiologist
For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”
Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
Ruling out a cardiac cause
The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.
“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”
Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”
Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.
A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.
The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”
‘The world’s most boring test’
For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”
“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”
Dr. Deal had no relevant financial disclosures.
*This article was updated on 10/25/2017.
CHICAGO – Syncope often is misdiagnosed in pediatric patients complaining of chest pain, and a new guideline released in 2017 could guide clinicians toward a more accurate differential diagnosis and help them know when immediate referral to cardiology or the emergency department is warranted.
“There are recent guidelines published this year which are helpful,” said Dr. Barbara Deal, the Getz Professor of Cardiology at Northwestern University in Chicago. “,” which is defined as transient loss of consciousness.
“Once you establish it is a simple vasovagal [cause], you need to educate patients on conditions that would promote this and the need to be anticipatory,” Dr. Deal said at the annual meeting of the American Academy of Pediatrics. “Further testing with an echo[cardiogram] should be done if you suspect heart disease or a rhythm disorder.”
Chest pain and syncope are common complaints that can lead to significant anxiety for patients, parents, and pediatric providers. The greatest cause of this anxiety is the prospect of a fatal or near-fatal event. An abnormal cardiac examination, any associated palpitations, and a history of urinary incontinence or traumatic injury are reasons to worry, she said. “Any of these should prompt an urgent consult to cardiology or the emergency department.”
Cardiac causes of chest pain include reflex or vasovagal syncope or even a more serious cardiac cause, such as arrhythmic or structural issues, Dr. Deal said. Symptoms that appear with exertion or stress also are very worrisome. “You would know if they have a heart murmur or stenosis – it’s these other things that don’t present with a cardiac abnormality: hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy,” she said. “If they have symptoms on exertion, pay attention. This is not good.”
Syncope often is misdiagnosed, Dr. Deal said. Approximately 35%-48% of patients classified as having syncope do not have actual syncope;rather they experience dizziness rather than a loss of consciousness. In a study of 194 children, for example, the leading etiologies diagnosed after evaluation for syncope included simple fainting in 49%, a vasopressor/vasovagal response in 14%, and possible seizure in 14% (J Am Coll Cardiol. 1997;29[6]:1039-45). Seven percent were diagnosed with syncope not otherwise specified in this series. Some other causes included psychogenic or orthostatic ones, hyperventilation, dysmenorrhea, vertigo, dehydration, trauma, stress, exhaustion, or an infectious condition.*
“When should you be thinking life-threatening syncope?” Dr. Deal asked. Arrhythmic disorders that are heritable, such as an ion channelopathy, are an example. “They don’t always feel the racing heartbeat, but they feel something is not right; they feel a sense of impending doom. Some families report signs during exercise like swimming, seizures, gargling noises, or unusual symptoms on awakening.”
Dr. Deal noted that ages 3-24 years are “the problem territory for cardiac arrest.” In this age group, 43%-55% of cardiac arrests are associated with hypertrophic cardiomyopathy or arrhythmias; about one in three will have prior syncope. “These causes are not detectable on physical examination and often are not detectable with ECG only,” adding to the differential diagnosis challenges.*
Refer to a pediatric cardiologist
For this reason and others, referral to a pediatric cardiologist is indicated instead of a consult with an adult cardiologist, Dr. Deal said. “You know how your kids will start with ‘no offense.’ Like, ‘no offense, Mom, but your hair looks awful.’ With moderate offense intended, having an adult cardiologist read a pediatric ECG and clear them is not adequate. They will be looking for ischemia or A-fib [atrial fibrillation]; they’re not looking for long QT syndrome, arrhythmogenic cardiomyopathy, or abnormal T waves.”
Early detection of long QT syndrome is optimal, Dr. Deal said, because symptom onset often is between infancy and age 7 years. In addition, mortality is highest in the first 2 decades of life. “I think this could be why adult cardiologists are not as concerned as we are,” Dr. Deal said. “The bad ones die before they reach adulthood.”
Ruling out a cardiac cause
The 2017 joint guideline defined syncope as a transient loss of consciousness. “By definition, you pass out, you’re not aware of where you are, and you cannot hear,” Dr. Deal said. If a patient reports they could hear people talking, they may have lost postural tone, but they did not have syncope, she added.
“Sometimes, we see teenagers who are said to pass out and are unresponsive for 5 minutes, 10 minutes, or 20 minutes. I’m usually relieved to hear that because that gets cardiac off the hook,” Dr. Deal said. “There is nothing cardiac that makes you pass out for 20 minutes, unless people are resuscitating you.” She added, “I’m not suggesting it’s not a significant problem that you need to get to the bottom of.”
Noncardiac etiologies can be neurologic, metabolic, drug-induced, or psychogenic. “This is where the detective work comes in.”
Keep clinical suspicion high for psychogenic syncope, Dr. Deal said. Psychogenic episodes stem from significant psychological stress, often something so profoundly bothersome that they cannot cope, such as sexual abuse.
A helpful tip for diagnosing the less worrisome vasovagal syncope is asking whether a patient was sitting to standing or standing a long time before an episode, Dr. Deal said. “A common complaint is that the family went to airport, got up early, didn’t eat, and ended up standing for a long time. Kids will say they don’t feel well, they fall down, and all hell breaks loose.” Other causes of vasovagal syncope include stress, pain, or a situational trigger, for example, when a person faints during a blood draw or immunization.
The 2017 guideline also set forth the evidence behind various medications used to lower the risk of syncope. However, Dr. Deal said, “If syncope only happens every 3 years when you go to an airport, it’s probably not worth daily therapy to prevent that.”
‘The world’s most boring test’
For the most part, lifestyle measures should work to address vasovagal syncope. A tilt table test can be useful to aid the differential diagnosis, but it’s recommended only when the etiology is unclear, Dr. Deal said. On the plus side, the tilt table test allows clinicians to reproduce symptoms in a controlled environment. On the downside, she added, “It’s the world’s most boring test. It’s a challenge for the cardiologist to stay awake. It’s very boring, until all hell breaks loose.”
“I find this helpful in the setting of kids with seizures and for kids with this atypical syncope where you just cannot convince the family that these 20-minute episodes of loss of consciousness are not near-death episodes.”
Dr. Deal had no relevant financial disclosures.
*This article was updated on 10/25/2017.
EXPERT ANALYSIS FROM AAP 2017
Flu vaccine appears ineffective in young leukemia patients
Vaccination may fail to protect young leukemia patients from developing influenza during cancer treatment, according to research published in the Journal of Pediatrics.
Researchers found that young patients with acute leukemia who received flu shots were just as likely as their unvaccinated peers to develop the flu.
The team said these results are preliminary, but they suggest a need for more research and additional efforts to prevent flu in young patients with leukemia.
“The annual flu shot, whose side effects are generally mild and short-lived, is still recommended for patients with acute leukemia who are being treated for their disease,” said study author Elisabeth Adderson, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.
“However, the results do highlight the need for additional research in this area and for us to redouble our efforts to protect our patients through other means.”
In this retrospective study, Dr Adderson and her colleagues looked at rates of flu infection during 3 successive flu seasons (2010-2013) in 498 patients treated for acute leukemia at St. Jude.
The patients’ median age was 6 years (range, 1-21). Most patients had acute lymphoblastic leukemia (ALL, 94%), though some had acute myeloid leukemia (4.8%) or mixed-lineage leukemia (1.2%).
Most patients (n=354) received flu shots, including 98 patients who received booster doses. The remaining 144 patients were not vaccinated.
The vaccinated patients received the trivalent vaccine, which is designed to protect against 3 flu strains predicted to be in wide circulation during a particular flu season. The vaccine was a fairly good match for circulating flu viruses during the flu seasons included in this analysis.
Demographic characteristic were largely similar between vaccinated and unvaccinated patients. The exceptions were that more vaccinated patients had ALL (95.5% vs 90.3%; P=0.034) and vaccinated patients were more likely to be in a low-intensity phase of cancer therapy (90.7% vs 73.6%, P<0.0001).
Results
There were no significant differences between vaccinated and unvaccinated patients when it came to flu rates or rates of flu-like illnesses.
There were 37 episodes of flu in vaccinated patients and 16 episodes in unvaccinated patients. The rates (per 1000 patient days) were 0.73 and 0.70, respectively (P=0.874).
There were 123 cases of flu-like illnesses in vaccinated patients and 55 cases in unvaccinated patients. The rates were 2.44 and 2.41, respectively (P=0.932).
Likewise, there was no significant difference in the rates of flu or flu-like illnesses between patients who received 1 dose of flu vaccine and those who received 2 doses.
The flu rates were 0.60 and 1.02, respectively (P=0.107). And the rates of flu-like illnesses were 2.42 and 2.73, respectively (P=0.529).
Dr Adderson said additional research is needed to determine if a subset of young leukemia patients may benefit from vaccination.
She added that patients at risk of flu should practice good hand hygiene and avoid crowds during the flu season. Patients may also benefit from “cocooning,” a process that focuses on getting family members, healthcare providers, and others in close contact with at-risk patients vaccinated. 
Vaccination may fail to protect young leukemia patients from developing influenza during cancer treatment, according to research published in the Journal of Pediatrics.
Researchers found that young patients with acute leukemia who received flu shots were just as likely as their unvaccinated peers to develop the flu.
The team said these results are preliminary, but they suggest a need for more research and additional efforts to prevent flu in young patients with leukemia.
“The annual flu shot, whose side effects are generally mild and short-lived, is still recommended for patients with acute leukemia who are being treated for their disease,” said study author Elisabeth Adderson, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.
“However, the results do highlight the need for additional research in this area and for us to redouble our efforts to protect our patients through other means.”
In this retrospective study, Dr Adderson and her colleagues looked at rates of flu infection during 3 successive flu seasons (2010-2013) in 498 patients treated for acute leukemia at St. Jude.
The patients’ median age was 6 years (range, 1-21). Most patients had acute lymphoblastic leukemia (ALL, 94%), though some had acute myeloid leukemia (4.8%) or mixed-lineage leukemia (1.2%).
Most patients (n=354) received flu shots, including 98 patients who received booster doses. The remaining 144 patients were not vaccinated.
The vaccinated patients received the trivalent vaccine, which is designed to protect against 3 flu strains predicted to be in wide circulation during a particular flu season. The vaccine was a fairly good match for circulating flu viruses during the flu seasons included in this analysis.
Demographic characteristic were largely similar between vaccinated and unvaccinated patients. The exceptions were that more vaccinated patients had ALL (95.5% vs 90.3%; P=0.034) and vaccinated patients were more likely to be in a low-intensity phase of cancer therapy (90.7% vs 73.6%, P<0.0001).
Results
There were no significant differences between vaccinated and unvaccinated patients when it came to flu rates or rates of flu-like illnesses.
There were 37 episodes of flu in vaccinated patients and 16 episodes in unvaccinated patients. The rates (per 1000 patient days) were 0.73 and 0.70, respectively (P=0.874).
There were 123 cases of flu-like illnesses in vaccinated patients and 55 cases in unvaccinated patients. The rates were 2.44 and 2.41, respectively (P=0.932).
Likewise, there was no significant difference in the rates of flu or flu-like illnesses between patients who received 1 dose of flu vaccine and those who received 2 doses.
The flu rates were 0.60 and 1.02, respectively (P=0.107). And the rates of flu-like illnesses were 2.42 and 2.73, respectively (P=0.529).
Dr Adderson said additional research is needed to determine if a subset of young leukemia patients may benefit from vaccination.
She added that patients at risk of flu should practice good hand hygiene and avoid crowds during the flu season. Patients may also benefit from “cocooning,” a process that focuses on getting family members, healthcare providers, and others in close contact with at-risk patients vaccinated.
Vaccination may fail to protect young leukemia patients from developing influenza during cancer treatment, according to research published in the Journal of Pediatrics.
Researchers found that young patients with acute leukemia who received flu shots were just as likely as their unvaccinated peers to develop the flu.
The team said these results are preliminary, but they suggest a need for more research and additional efforts to prevent flu in young patients with leukemia.
“The annual flu shot, whose side effects are generally mild and short-lived, is still recommended for patients with acute leukemia who are being treated for their disease,” said study author Elisabeth Adderson, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.
“However, the results do highlight the need for additional research in this area and for us to redouble our efforts to protect our patients through other means.”
In this retrospective study, Dr Adderson and her colleagues looked at rates of flu infection during 3 successive flu seasons (2010-2013) in 498 patients treated for acute leukemia at St. Jude.
The patients’ median age was 6 years (range, 1-21). Most patients had acute lymphoblastic leukemia (ALL, 94%), though some had acute myeloid leukemia (4.8%) or mixed-lineage leukemia (1.2%).
Most patients (n=354) received flu shots, including 98 patients who received booster doses. The remaining 144 patients were not vaccinated.
The vaccinated patients received the trivalent vaccine, which is designed to protect against 3 flu strains predicted to be in wide circulation during a particular flu season. The vaccine was a fairly good match for circulating flu viruses during the flu seasons included in this analysis.
Demographic characteristic were largely similar between vaccinated and unvaccinated patients. The exceptions were that more vaccinated patients had ALL (95.5% vs 90.3%; P=0.034) and vaccinated patients were more likely to be in a low-intensity phase of cancer therapy (90.7% vs 73.6%, P<0.0001).
Results
There were no significant differences between vaccinated and unvaccinated patients when it came to flu rates or rates of flu-like illnesses.
There were 37 episodes of flu in vaccinated patients and 16 episodes in unvaccinated patients. The rates (per 1000 patient days) were 0.73 and 0.70, respectively (P=0.874).
There were 123 cases of flu-like illnesses in vaccinated patients and 55 cases in unvaccinated patients. The rates were 2.44 and 2.41, respectively (P=0.932).
Likewise, there was no significant difference in the rates of flu or flu-like illnesses between patients who received 1 dose of flu vaccine and those who received 2 doses.
The flu rates were 0.60 and 1.02, respectively (P=0.107). And the rates of flu-like illnesses were 2.42 and 2.73, respectively (P=0.529).
Dr Adderson said additional research is needed to determine if a subset of young leukemia patients may benefit from vaccination.
She added that patients at risk of flu should practice good hand hygiene and avoid crowds during the flu season. Patients may also benefit from “cocooning,” a process that focuses on getting family members, healthcare providers, and others in close contact with at-risk patients vaccinated.
Research progress in a short time window
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.
My research experience this summer has been full of learning both clinical and academic aspects of medicine. I had the opportunity to observe my mentor plus other hospitalists rounding on patients, and sit in on presentations to hear about the spectacular work that different faculty members are implementing. This has helped me gain a better understanding of hospital medicine, and really sparked my interest in the field.
I love that hospitalists can play a major role in treating the sickest of patients, while at the same time work to investigate ways to make the patients’ time at a hospital a better experience.
My mentor, Dr. Patrick Brady, has been very helpful giving me insight on research methods for our project and how best to use the data we have collected. We were able to make some adjustments in our exclusion criteria for the patients included in the retrospective case control study, so that I have time to collect several clinical characteristics of each patient who underwent an emergency transfer. While going over several emergency transfer cases, I have learned quite a bit of clinical information. One example of what I’ve learned involves rapid sequence intubation drugs when endotracheal intubation procedures are done. The procedure requires quick onset sedatives and pain medications in addition to neuromuscular blocking agents to rapidly numb and sedate the patient in order to put in the tube.
We are wrapping up this week and beginning to run some simple statistical analyses on the data. I hope to have some insight on the incidence and descriptors of emergency transfer cases in Cincinnati Children’s Hospital by the end of the week. I am preparing to begin writing and creating presentations for dissemination.
Reflecting back on my work this summer, I am encouraged by the amount of progress that I was able to make in the short period of time. Completing a research project over a nine-week period is a very challenging task as it comes with many limitations. However, Dr. Brady helped me realize that important questions can still be answered if the project is designed efficiently. I could see myself doing similar research in my future as a physician. I very much like the idea of studying what is clinically right in front of you.
Farah Hussain is a 2nd-year medical student at University of Cincinnati College of Medicine and student researcher at Cincinnati Children’s Hospital Medical Center. Her research interests involve bettering patient care to vulnerable populations.
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.
My research experience this summer has been full of learning both clinical and academic aspects of medicine. I had the opportunity to observe my mentor plus other hospitalists rounding on patients, and sit in on presentations to hear about the spectacular work that different faculty members are implementing. This has helped me gain a better understanding of hospital medicine, and really sparked my interest in the field.
I love that hospitalists can play a major role in treating the sickest of patients, while at the same time work to investigate ways to make the patients’ time at a hospital a better experience.
My mentor, Dr. Patrick Brady, has been very helpful giving me insight on research methods for our project and how best to use the data we have collected. We were able to make some adjustments in our exclusion criteria for the patients included in the retrospective case control study, so that I have time to collect several clinical characteristics of each patient who underwent an emergency transfer. While going over several emergency transfer cases, I have learned quite a bit of clinical information. One example of what I’ve learned involves rapid sequence intubation drugs when endotracheal intubation procedures are done. The procedure requires quick onset sedatives and pain medications in addition to neuromuscular blocking agents to rapidly numb and sedate the patient in order to put in the tube.
We are wrapping up this week and beginning to run some simple statistical analyses on the data. I hope to have some insight on the incidence and descriptors of emergency transfer cases in Cincinnati Children’s Hospital by the end of the week. I am preparing to begin writing and creating presentations for dissemination.
Reflecting back on my work this summer, I am encouraged by the amount of progress that I was able to make in the short period of time. Completing a research project over a nine-week period is a very challenging task as it comes with many limitations. However, Dr. Brady helped me realize that important questions can still be answered if the project is designed efficiently. I could see myself doing similar research in my future as a physician. I very much like the idea of studying what is clinically right in front of you.
Farah Hussain is a 2nd-year medical student at University of Cincinnati College of Medicine and student researcher at Cincinnati Children’s Hospital Medical Center. Her research interests involve bettering patient care to vulnerable populations.
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.
My research experience this summer has been full of learning both clinical and academic aspects of medicine. I had the opportunity to observe my mentor plus other hospitalists rounding on patients, and sit in on presentations to hear about the spectacular work that different faculty members are implementing. This has helped me gain a better understanding of hospital medicine, and really sparked my interest in the field.
I love that hospitalists can play a major role in treating the sickest of patients, while at the same time work to investigate ways to make the patients’ time at a hospital a better experience.
My mentor, Dr. Patrick Brady, has been very helpful giving me insight on research methods for our project and how best to use the data we have collected. We were able to make some adjustments in our exclusion criteria for the patients included in the retrospective case control study, so that I have time to collect several clinical characteristics of each patient who underwent an emergency transfer. While going over several emergency transfer cases, I have learned quite a bit of clinical information. One example of what I’ve learned involves rapid sequence intubation drugs when endotracheal intubation procedures are done. The procedure requires quick onset sedatives and pain medications in addition to neuromuscular blocking agents to rapidly numb and sedate the patient in order to put in the tube.
We are wrapping up this week and beginning to run some simple statistical analyses on the data. I hope to have some insight on the incidence and descriptors of emergency transfer cases in Cincinnati Children’s Hospital by the end of the week. I am preparing to begin writing and creating presentations for dissemination.
Reflecting back on my work this summer, I am encouraged by the amount of progress that I was able to make in the short period of time. Completing a research project over a nine-week period is a very challenging task as it comes with many limitations. However, Dr. Brady helped me realize that important questions can still be answered if the project is designed efficiently. I could see myself doing similar research in my future as a physician. I very much like the idea of studying what is clinically right in front of you.
Farah Hussain is a 2nd-year medical student at University of Cincinnati College of Medicine and student researcher at Cincinnati Children’s Hospital Medical Center. Her research interests involve bettering patient care to vulnerable populations.
Everolimus has long-term efficacy in tuberous sclerosis complex
SAN DIEGO – Everolimus reduces the frequency of epileptic seizures in patients with tuberous sclerosis complex (TSC), and its effect appears to gain strength over time. By the end of an extension study, half of patients had at least a 31.7% reduction in seizure frequency at 18 weeks, and that percentage rose to 56.9% at 2 years.
The drug was chosen because it inhibits mammalian target of rapamycin (mTOR), which plays a central role in protein synthesis, cell division, and other vital processes. In patients with TSC, the kinase is overactive, and this leads to abnormalities in brain development. Overall, 85% of TSC patients experience seizures, and 60% are refractory to antiepileptic drugs.
The success of everolimus (Afinitor) is encouraging, and it’s the first epilepsy drug to be chosen for its mechanism of action, David Neal Franz, MD, said in an interview. “It has been used off label, but this study really shows that it has a statistically significant benefit that improves over time. A lot of things are used off label, but most don’t have this kind of class II evidence to support being used,” said Dr. Franz, who presented the study at the annual meeting of the American Neurological Association.
The drug was particularly effective in children, who experienced a greater reduction in seizure frequency over time. That suggests that earlier treatment with everolimus could counter some of the damage in these patients before it becomes entrenched. “We’re planning to do studies to evaluate that. Because if you can avoid intractable epilepsy and its effects on development, there’s the potential to have a very significant benefit for children,” said Dr. Franz, who is a professor of pediatrics and neurology and founding director of the Tuberous Sclerosis Clinic at the University of Cincinnati. He noted that some previous studies showed that early treatment of infantile spasms is associated with lower risk of intellectual disability and autism.
The study enrolled 361 TSC patients with epilepsy across a wide age range (2-65 years). Their epilepsy had remained uncontrolled following treatment with at least six previous drugs. The core phase of the trial lasted 18 weeks, followed by an extension phase in which patients in the placebo group were switched to everolimus with a target dose of 3-15 ng/mL.
The primary efficacy outcome was the change in weekly seizure frequency. The researchers defined a response as a 50% or higher reduction.
In the original pivotal trial (EXIST-3), 15.1% of patients on placebo responded (95% confidence interval, 9.2%-22.8%) at week 18, compared with 28.2% of patients receiving a 3-7 ng/mL dose of everolimus (95% CI, 20.3%-37.3%; P = .0077) and 40% of patients receiving a 9-15 ng/mL dose of everolimus (95% CI, 31.5%-49%; P less than .0001).
The response rate at 18 weeks of treatment when combining both the original everolimus-treated patients and also the group switching over to everolimus in the extension phase was 31% (95% CI, 26.2%-36.1%). By 1 year, 46.6% had responded (95% CI, 40.9%-52.5%), and 57.7% had responded at 2 years (95% CI, 49.7%-65.4%).
The median percentage reduction in seizure frequency rose from 31.7% at week 18 (95% CI, 28.5%-36.1%) to 46.7% at 1 year (95% CI, 40.2%-54.0%) and 56.9% at 2 years (95% CI, 50%-68.4%).
Younger patients experienced greater improvements over time. At 2 years, 76% of 101 patients aged 0-6 years had responded (95% CI, 58.8%-88.2%), compared with 58.5% of patients aged 6-12 years (95% CI, 44.1%-71.9%), 51.1% of patients aged 12-18 years (95% CI, 35.8%-66.3%), and 43% of patients 18 years and older (95% CI, 24.5%-62.8%).
A sensitivity analysis of patients who discontinued the drug and were categorized as nonresponders showed the drug was still associated with a risk reduction of 30.2% at week 18 (95% CI, 25.5%-35.2%), 38.8% at 1 year (95% CI, 33.7%-44.1%), and 41% at 2 years (95% CI, 34.6%-47.7%).
Adverse events declined over time from 76.1% during the first 6 months of treatment to 46.8% at 1 year and 45.2% at 2 years. A total of 40.2% of patients experienced grade III/IV adverse events, and 13% of patients discontinued medication as a result. Another 1.7% experienced pneumonia, and 1.4% experienced stomatitis.
The most concerning side effects noted were tied to infection risk, which was not surprising given that everolimus is an immunosuppressive agent that is also used to prevent organ rejection. “The good thing is that you can hold everolimus when patients get sick or have a fever, and it doesn’t immediately lose efficacy. It binds avidly to mTOR, and so you can often go several weeks off the drug before you see loss of seizure control,” Dr. Franz said.
The study was funded by Novartis. Dr. Franz has received travel funding and honoraria from Novartis.
SAN DIEGO – Everolimus reduces the frequency of epileptic seizures in patients with tuberous sclerosis complex (TSC), and its effect appears to gain strength over time. By the end of an extension study, half of patients had at least a 31.7% reduction in seizure frequency at 18 weeks, and that percentage rose to 56.9% at 2 years.
The drug was chosen because it inhibits mammalian target of rapamycin (mTOR), which plays a central role in protein synthesis, cell division, and other vital processes. In patients with TSC, the kinase is overactive, and this leads to abnormalities in brain development. Overall, 85% of TSC patients experience seizures, and 60% are refractory to antiepileptic drugs.
The success of everolimus (Afinitor) is encouraging, and it’s the first epilepsy drug to be chosen for its mechanism of action, David Neal Franz, MD, said in an interview. “It has been used off label, but this study really shows that it has a statistically significant benefit that improves over time. A lot of things are used off label, but most don’t have this kind of class II evidence to support being used,” said Dr. Franz, who presented the study at the annual meeting of the American Neurological Association.
The drug was particularly effective in children, who experienced a greater reduction in seizure frequency over time. That suggests that earlier treatment with everolimus could counter some of the damage in these patients before it becomes entrenched. “We’re planning to do studies to evaluate that. Because if you can avoid intractable epilepsy and its effects on development, there’s the potential to have a very significant benefit for children,” said Dr. Franz, who is a professor of pediatrics and neurology and founding director of the Tuberous Sclerosis Clinic at the University of Cincinnati. He noted that some previous studies showed that early treatment of infantile spasms is associated with lower risk of intellectual disability and autism.
The study enrolled 361 TSC patients with epilepsy across a wide age range (2-65 years). Their epilepsy had remained uncontrolled following treatment with at least six previous drugs. The core phase of the trial lasted 18 weeks, followed by an extension phase in which patients in the placebo group were switched to everolimus with a target dose of 3-15 ng/mL.
The primary efficacy outcome was the change in weekly seizure frequency. The researchers defined a response as a 50% or higher reduction.
In the original pivotal trial (EXIST-3), 15.1% of patients on placebo responded (95% confidence interval, 9.2%-22.8%) at week 18, compared with 28.2% of patients receiving a 3-7 ng/mL dose of everolimus (95% CI, 20.3%-37.3%; P = .0077) and 40% of patients receiving a 9-15 ng/mL dose of everolimus (95% CI, 31.5%-49%; P less than .0001).
The response rate at 18 weeks of treatment when combining both the original everolimus-treated patients and also the group switching over to everolimus in the extension phase was 31% (95% CI, 26.2%-36.1%). By 1 year, 46.6% had responded (95% CI, 40.9%-52.5%), and 57.7% had responded at 2 years (95% CI, 49.7%-65.4%).
The median percentage reduction in seizure frequency rose from 31.7% at week 18 (95% CI, 28.5%-36.1%) to 46.7% at 1 year (95% CI, 40.2%-54.0%) and 56.9% at 2 years (95% CI, 50%-68.4%).
Younger patients experienced greater improvements over time. At 2 years, 76% of 101 patients aged 0-6 years had responded (95% CI, 58.8%-88.2%), compared with 58.5% of patients aged 6-12 years (95% CI, 44.1%-71.9%), 51.1% of patients aged 12-18 years (95% CI, 35.8%-66.3%), and 43% of patients 18 years and older (95% CI, 24.5%-62.8%).
A sensitivity analysis of patients who discontinued the drug and were categorized as nonresponders showed the drug was still associated with a risk reduction of 30.2% at week 18 (95% CI, 25.5%-35.2%), 38.8% at 1 year (95% CI, 33.7%-44.1%), and 41% at 2 years (95% CI, 34.6%-47.7%).
Adverse events declined over time from 76.1% during the first 6 months of treatment to 46.8% at 1 year and 45.2% at 2 years. A total of 40.2% of patients experienced grade III/IV adverse events, and 13% of patients discontinued medication as a result. Another 1.7% experienced pneumonia, and 1.4% experienced stomatitis.
The most concerning side effects noted were tied to infection risk, which was not surprising given that everolimus is an immunosuppressive agent that is also used to prevent organ rejection. “The good thing is that you can hold everolimus when patients get sick or have a fever, and it doesn’t immediately lose efficacy. It binds avidly to mTOR, and so you can often go several weeks off the drug before you see loss of seizure control,” Dr. Franz said.
The study was funded by Novartis. Dr. Franz has received travel funding and honoraria from Novartis.
SAN DIEGO – Everolimus reduces the frequency of epileptic seizures in patients with tuberous sclerosis complex (TSC), and its effect appears to gain strength over time. By the end of an extension study, half of patients had at least a 31.7% reduction in seizure frequency at 18 weeks, and that percentage rose to 56.9% at 2 years.
The drug was chosen because it inhibits mammalian target of rapamycin (mTOR), which plays a central role in protein synthesis, cell division, and other vital processes. In patients with TSC, the kinase is overactive, and this leads to abnormalities in brain development. Overall, 85% of TSC patients experience seizures, and 60% are refractory to antiepileptic drugs.
The success of everolimus (Afinitor) is encouraging, and it’s the first epilepsy drug to be chosen for its mechanism of action, David Neal Franz, MD, said in an interview. “It has been used off label, but this study really shows that it has a statistically significant benefit that improves over time. A lot of things are used off label, but most don’t have this kind of class II evidence to support being used,” said Dr. Franz, who presented the study at the annual meeting of the American Neurological Association.
The drug was particularly effective in children, who experienced a greater reduction in seizure frequency over time. That suggests that earlier treatment with everolimus could counter some of the damage in these patients before it becomes entrenched. “We’re planning to do studies to evaluate that. Because if you can avoid intractable epilepsy and its effects on development, there’s the potential to have a very significant benefit for children,” said Dr. Franz, who is a professor of pediatrics and neurology and founding director of the Tuberous Sclerosis Clinic at the University of Cincinnati. He noted that some previous studies showed that early treatment of infantile spasms is associated with lower risk of intellectual disability and autism.
The study enrolled 361 TSC patients with epilepsy across a wide age range (2-65 years). Their epilepsy had remained uncontrolled following treatment with at least six previous drugs. The core phase of the trial lasted 18 weeks, followed by an extension phase in which patients in the placebo group were switched to everolimus with a target dose of 3-15 ng/mL.
The primary efficacy outcome was the change in weekly seizure frequency. The researchers defined a response as a 50% or higher reduction.
In the original pivotal trial (EXIST-3), 15.1% of patients on placebo responded (95% confidence interval, 9.2%-22.8%) at week 18, compared with 28.2% of patients receiving a 3-7 ng/mL dose of everolimus (95% CI, 20.3%-37.3%; P = .0077) and 40% of patients receiving a 9-15 ng/mL dose of everolimus (95% CI, 31.5%-49%; P less than .0001).
The response rate at 18 weeks of treatment when combining both the original everolimus-treated patients and also the group switching over to everolimus in the extension phase was 31% (95% CI, 26.2%-36.1%). By 1 year, 46.6% had responded (95% CI, 40.9%-52.5%), and 57.7% had responded at 2 years (95% CI, 49.7%-65.4%).
The median percentage reduction in seizure frequency rose from 31.7% at week 18 (95% CI, 28.5%-36.1%) to 46.7% at 1 year (95% CI, 40.2%-54.0%) and 56.9% at 2 years (95% CI, 50%-68.4%).
Younger patients experienced greater improvements over time. At 2 years, 76% of 101 patients aged 0-6 years had responded (95% CI, 58.8%-88.2%), compared with 58.5% of patients aged 6-12 years (95% CI, 44.1%-71.9%), 51.1% of patients aged 12-18 years (95% CI, 35.8%-66.3%), and 43% of patients 18 years and older (95% CI, 24.5%-62.8%).
A sensitivity analysis of patients who discontinued the drug and were categorized as nonresponders showed the drug was still associated with a risk reduction of 30.2% at week 18 (95% CI, 25.5%-35.2%), 38.8% at 1 year (95% CI, 33.7%-44.1%), and 41% at 2 years (95% CI, 34.6%-47.7%).
Adverse events declined over time from 76.1% during the first 6 months of treatment to 46.8% at 1 year and 45.2% at 2 years. A total of 40.2% of patients experienced grade III/IV adverse events, and 13% of patients discontinued medication as a result. Another 1.7% experienced pneumonia, and 1.4% experienced stomatitis.
The most concerning side effects noted were tied to infection risk, which was not surprising given that everolimus is an immunosuppressive agent that is also used to prevent organ rejection. “The good thing is that you can hold everolimus when patients get sick or have a fever, and it doesn’t immediately lose efficacy. It binds avidly to mTOR, and so you can often go several weeks off the drug before you see loss of seizure control,” Dr. Franz said.
The study was funded by Novartis. Dr. Franz has received travel funding and honoraria from Novartis.
AT ANA 2017
Key clinical point:
Major finding: The response rate rose from 31% at week 18 to 57.7% at 2 years.
Data source: An extension study of a double-blind, randomized, placebo-controlled trial (n = 361).
Disclosures: The study was funded by Novartis. Dr. Franz has received travel funding and honoraria from Novartis.
Rectal swabs concurred with stool tests in children with GI illness
SAN DIEGO – Clinicians who treat children with acute gastrointestinal illness should consider testing rectal swabs when they need to rapidly identify enteropathogens and cannot immediately obtain a bulk stool sample, Stephen Freedman, MD, said at an annual scientific meeting on infectious diseases.
Among 1,519 children and adolescents with diarrhea, vomiting, or both symptoms, diagnostic yields of paired stool and rectal swab specimens were 76% and 68%, respectively, Dr. Freedman reported on behalf of the Alberta Provincial Pediatric Enteric Infection Team.
Kappa values for concordance were 0.76 overall (95% confidence interval [CI], 0.71-0.80), .82 for viruses (0.79-0.86), and .74 for bacteria (0.68-0.80). A kappa value between 0.61 and 0.80 indicates “substantial” concordance between two results, while a value between 0.81 and 1.0 suggests “near perfect” concordance, explained Dr. Freedman of the University of Calgary (Alta.). In addition, 95% of health care providers and 82% of home caregivers considered rectal swabs easy to use, while 10% considered them unacceptable. “Recommendations against rectal swab use should be reconsidered,” he said.
Traditional testing of diarrheal bulk stool is highly specific, but burdensome and subject to various handling issues that can substantially delay diagnosis and outbreak detection, Dr. Freedman said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
“Flocked rectal swabs are used at the point of care and are quick and acceptable, but there are few precedents in the literature for their use in children or in patients with vomiting without diarrhea,” he said.
To help fill that gap, the researchers collected 1,147 stool specimens and 1,468 rectal swabs from patients under age 18 years who were seen at emergency departments in Calgary and Edmonton for diarrhea, vomiting, or both, with at least three episodes in the previous 24 hours. All of the patients had been ill for less than 7 days and had no detected psychiatric illness or neutropenia. Stool and rectal samples were evaluated three ways – by routine enteric bacterial culture, an in-house gastroenteric viral panel, and with the polymerase chain reaction-based Luminex xTAG Gastrointestinal Pathogen Panel. Swabs were taken by rotating them 360 degrees one time within the anus. Stool and swab specimens collected at home were stored at room temperature for less than 12 hours.
Among all paired specimens, 76% of stool samples and 68% of rectal swabs tested positive for at least one pathogen (P less than .0001). Thus, stool testing had about a 30% higher odds of detection than did swab testing in the same patient (OR, 1.3; 95% CI, 1.3-1.5). Odds ratios also favored stool testing in subgroups of patients with diarrhea (OR, 1.2; 95% CI, 1.1-1.4) or isolated vomiting (OR, 1.8; 95% CI, 1.5-2.1).
However, many stool specimens were never submitted, Dr. Freedman said. When the researchers assumed that these unsubmitted samples all tested negative, the diagnostic yield of stool samples fell to 57% and several odds ratios inverted in favor of rectal swabs. The study findings did not change when the researchers excluded positive results for Clostridium difficile in children younger than 2 years or when they restricted the analysis to paired specimens obtained within 24 hours.
The researchers are continuing to explore the diagnostic yield of rectal swab tests for multidrug-resistant pathogens, including those that are notifiable to public health departments, Dr. Freedman said.
Dr. Freedman disclosed ties to Copan Diagnostics, Luminex, and Alere.
SAN DIEGO – Clinicians who treat children with acute gastrointestinal illness should consider testing rectal swabs when they need to rapidly identify enteropathogens and cannot immediately obtain a bulk stool sample, Stephen Freedman, MD, said at an annual scientific meeting on infectious diseases.
Among 1,519 children and adolescents with diarrhea, vomiting, or both symptoms, diagnostic yields of paired stool and rectal swab specimens were 76% and 68%, respectively, Dr. Freedman reported on behalf of the Alberta Provincial Pediatric Enteric Infection Team.
Kappa values for concordance were 0.76 overall (95% confidence interval [CI], 0.71-0.80), .82 for viruses (0.79-0.86), and .74 for bacteria (0.68-0.80). A kappa value between 0.61 and 0.80 indicates “substantial” concordance between two results, while a value between 0.81 and 1.0 suggests “near perfect” concordance, explained Dr. Freedman of the University of Calgary (Alta.). In addition, 95% of health care providers and 82% of home caregivers considered rectal swabs easy to use, while 10% considered them unacceptable. “Recommendations against rectal swab use should be reconsidered,” he said.
Traditional testing of diarrheal bulk stool is highly specific, but burdensome and subject to various handling issues that can substantially delay diagnosis and outbreak detection, Dr. Freedman said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
“Flocked rectal swabs are used at the point of care and are quick and acceptable, but there are few precedents in the literature for their use in children or in patients with vomiting without diarrhea,” he said.
To help fill that gap, the researchers collected 1,147 stool specimens and 1,468 rectal swabs from patients under age 18 years who were seen at emergency departments in Calgary and Edmonton for diarrhea, vomiting, or both, with at least three episodes in the previous 24 hours. All of the patients had been ill for less than 7 days and had no detected psychiatric illness or neutropenia. Stool and rectal samples were evaluated three ways – by routine enteric bacterial culture, an in-house gastroenteric viral panel, and with the polymerase chain reaction-based Luminex xTAG Gastrointestinal Pathogen Panel. Swabs were taken by rotating them 360 degrees one time within the anus. Stool and swab specimens collected at home were stored at room temperature for less than 12 hours.
Among all paired specimens, 76% of stool samples and 68% of rectal swabs tested positive for at least one pathogen (P less than .0001). Thus, stool testing had about a 30% higher odds of detection than did swab testing in the same patient (OR, 1.3; 95% CI, 1.3-1.5). Odds ratios also favored stool testing in subgroups of patients with diarrhea (OR, 1.2; 95% CI, 1.1-1.4) or isolated vomiting (OR, 1.8; 95% CI, 1.5-2.1).
However, many stool specimens were never submitted, Dr. Freedman said. When the researchers assumed that these unsubmitted samples all tested negative, the diagnostic yield of stool samples fell to 57% and several odds ratios inverted in favor of rectal swabs. The study findings did not change when the researchers excluded positive results for Clostridium difficile in children younger than 2 years or when they restricted the analysis to paired specimens obtained within 24 hours.
The researchers are continuing to explore the diagnostic yield of rectal swab tests for multidrug-resistant pathogens, including those that are notifiable to public health departments, Dr. Freedman said.
Dr. Freedman disclosed ties to Copan Diagnostics, Luminex, and Alere.
SAN DIEGO – Clinicians who treat children with acute gastrointestinal illness should consider testing rectal swabs when they need to rapidly identify enteropathogens and cannot immediately obtain a bulk stool sample, Stephen Freedman, MD, said at an annual scientific meeting on infectious diseases.
Among 1,519 children and adolescents with diarrhea, vomiting, or both symptoms, diagnostic yields of paired stool and rectal swab specimens were 76% and 68%, respectively, Dr. Freedman reported on behalf of the Alberta Provincial Pediatric Enteric Infection Team.
Kappa values for concordance were 0.76 overall (95% confidence interval [CI], 0.71-0.80), .82 for viruses (0.79-0.86), and .74 for bacteria (0.68-0.80). A kappa value between 0.61 and 0.80 indicates “substantial” concordance between two results, while a value between 0.81 and 1.0 suggests “near perfect” concordance, explained Dr. Freedman of the University of Calgary (Alta.). In addition, 95% of health care providers and 82% of home caregivers considered rectal swabs easy to use, while 10% considered them unacceptable. “Recommendations against rectal swab use should be reconsidered,” he said.
Traditional testing of diarrheal bulk stool is highly specific, but burdensome and subject to various handling issues that can substantially delay diagnosis and outbreak detection, Dr. Freedman said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
“Flocked rectal swabs are used at the point of care and are quick and acceptable, but there are few precedents in the literature for their use in children or in patients with vomiting without diarrhea,” he said.
To help fill that gap, the researchers collected 1,147 stool specimens and 1,468 rectal swabs from patients under age 18 years who were seen at emergency departments in Calgary and Edmonton for diarrhea, vomiting, or both, with at least three episodes in the previous 24 hours. All of the patients had been ill for less than 7 days and had no detected psychiatric illness or neutropenia. Stool and rectal samples were evaluated three ways – by routine enteric bacterial culture, an in-house gastroenteric viral panel, and with the polymerase chain reaction-based Luminex xTAG Gastrointestinal Pathogen Panel. Swabs were taken by rotating them 360 degrees one time within the anus. Stool and swab specimens collected at home were stored at room temperature for less than 12 hours.
Among all paired specimens, 76% of stool samples and 68% of rectal swabs tested positive for at least one pathogen (P less than .0001). Thus, stool testing had about a 30% higher odds of detection than did swab testing in the same patient (OR, 1.3; 95% CI, 1.3-1.5). Odds ratios also favored stool testing in subgroups of patients with diarrhea (OR, 1.2; 95% CI, 1.1-1.4) or isolated vomiting (OR, 1.8; 95% CI, 1.5-2.1).
However, many stool specimens were never submitted, Dr. Freedman said. When the researchers assumed that these unsubmitted samples all tested negative, the diagnostic yield of stool samples fell to 57% and several odds ratios inverted in favor of rectal swabs. The study findings did not change when the researchers excluded positive results for Clostridium difficile in children younger than 2 years or when they restricted the analysis to paired specimens obtained within 24 hours.
The researchers are continuing to explore the diagnostic yield of rectal swab tests for multidrug-resistant pathogens, including those that are notifiable to public health departments, Dr. Freedman said.
Dr. Freedman disclosed ties to Copan Diagnostics, Luminex, and Alere.
AT IDWEEK 2017
Key clinical point: and cannot immediately obtain a bulk stool sample.
Major finding: Diagnostic yields of paired stool and rectal swab specimens were 76% and 68%, respectively.
Data source: A multicenter retrospective cohort study of 1,519 children and adolescents with acute-onset diarrhea, vomiting, or both.
Disclosures: Dr. Freedman disclosed ties to Copan Diagnostics, Luminex, and Alere.