Heidi Splete

MIAMI — A daily dose of intravenous ertapenem for intraabdominal infections proved as effective as piperacillin/tazobactam administered every 6 hours, Nicholas Namias, M.D., said in a poster presented at the joint annual meeting of the Surgical Infection Society and the Surgical Infection Society-Europe.

The randomized, double-blind study included 494 men and women aged at least 18 years who had systemic inflammatory responses and physical findings suggestive of intraabdominal infections resulting from surgical interventions such as open laparotomy, laparoscopic surgery, and percutaneous drainage.

A total of 247 received 1 gram of intravenous ertapenem per day and 247 received 3.375 g of intravenous piperacillin/tazobactam every 6 hours for 4–14 days, wrote Dr. Namias, of the University of Miami, and his colleagues.

Response rates were similar. A total of 122 ertapenem patients and 107 piperacillin/tazobactam patients were microbiologically evaluable at 2 weeks, and favorable clinical responses were shown in 82.1% and 81.7%, respectively. A total of 112 ertapenem patients and 94 piperacillin/tazobactam patients were microbiologically evaluable for a second follow up at 4–6 weeks, and they had response rates of 78.9% and 79.3%, respectively.

The top three organisms were Streptococcus species, Escherichia coli, and Peptostreptococcus micros. Response rates of ertapenem compared with piperacillin/tazobactam against each of these species, respectively, were 86.4% vs. 76.0%, 85.3% vs. 85.4%, and 85.0% vs. 73.3%.

A total of 69% of patients in each group reported at least one adverse experience, and 1.6% of each group discontinued the medication due to serious adverse experiences. During the course of the therapy and up to 14 days' follow-up, 6 patients in the ertapenem group died, compared with 10 patients in the piperacillin/tazobactam group. An additional two ertapenem patients and three piperacillin/tazobactam patients died due to clinical adverse events after the 14-day follow up.

MIAMI — A daily dose of intravenous ertapenem for intraabdominal infections proved as effective as piperacillin/tazobactam administered every 6 hours, Nicholas Namias, M.D., said in a poster presented at the joint annual meeting of the Surgical Infection Society and the Surgical Infection Society-Europe.

The randomized, double-blind study included 494 men and women aged at least 18 years who had systemic inflammatory responses and physical findings suggestive of intraabdominal infections resulting from surgical interventions such as open laparotomy, laparoscopic surgery, and percutaneous drainage.

A total of 247 received 1 gram of intravenous ertapenem per day and 247 received 3.375 g of intravenous piperacillin/tazobactam every 6 hours for 4–14 days, wrote Dr. Namias, of the University of Miami, and his colleagues.

Response rates were similar. A total of 122 ertapenem patients and 107 piperacillin/tazobactam patients were microbiologically evaluable at 2 weeks, and favorable clinical responses were shown in 82.1% and 81.7%, respectively. A total of 112 ertapenem patients and 94 piperacillin/tazobactam patients were microbiologically evaluable for a second follow up at 4–6 weeks, and they had response rates of 78.9% and 79.3%, respectively.

The top three organisms were Streptococcus species, Escherichia coli, and Peptostreptococcus micros. Response rates of ertapenem compared with piperacillin/tazobactam against each of these species, respectively, were 86.4% vs. 76.0%, 85.3% vs. 85.4%, and 85.0% vs. 73.3%.

A total of 69% of patients in each group reported at least one adverse experience, and 1.6% of each group discontinued the medication due to serious adverse experiences. During the course of the therapy and up to 14 days' follow-up, 6 patients in the ertapenem group died, compared with 10 patients in the piperacillin/tazobactam group. An additional two ertapenem patients and three piperacillin/tazobactam patients died due to clinical adverse events after the 14-day follow up.

MIAMI — A daily dose of intravenous ertapenem for intraabdominal infections proved as effective as piperacillin/tazobactam administered every 6 hours, Nicholas Namias, M.D., said in a poster presented at the joint annual meeting of the Surgical Infection Society and the Surgical Infection Society-Europe.

The randomized, double-blind study included 494 men and women aged at least 18 years who had systemic inflammatory responses and physical findings suggestive of intraabdominal infections resulting from surgical interventions such as open laparotomy, laparoscopic surgery, and percutaneous drainage.

A total of 247 received 1 gram of intravenous ertapenem per day and 247 received 3.375 g of intravenous piperacillin/tazobactam every 6 hours for 4–14 days, wrote Dr. Namias, of the University of Miami, and his colleagues.

Response rates were similar. A total of 122 ertapenem patients and 107 piperacillin/tazobactam patients were microbiologically evaluable at 2 weeks, and favorable clinical responses were shown in 82.1% and 81.7%, respectively. A total of 112 ertapenem patients and 94 piperacillin/tazobactam patients were microbiologically evaluable for a second follow up at 4–6 weeks, and they had response rates of 78.9% and 79.3%, respectively.

The top three organisms were Streptococcus species, Escherichia coli, and Peptostreptococcus micros. Response rates of ertapenem compared with piperacillin/tazobactam against each of these species, respectively, were 86.4% vs. 76.0%, 85.3% vs. 85.4%, and 85.0% vs. 73.3%.

A total of 69% of patients in each group reported at least one adverse experience, and 1.6% of each group discontinued the medication due to serious adverse experiences. During the course of the therapy and up to 14 days' follow-up, 6 patients in the ertapenem group died, compared with 10 patients in the piperacillin/tazobactam group. An additional two ertapenem patients and three piperacillin/tazobactam patients died due to clinical adverse events after the 14-day follow up.

WASHINGTON — A whopping 97% of 78 patients hospitalized for minimal trauma fractures had vitamin D levels of less than 30 ng/mL, Christine Simonelli, M.D., said at an international symposium sponsored by the National Osteoporosis Foundation.

Even the patients who took at least 400 IU of vitamin D had inadequate vitamin D levels, added Dr. Simonelli of HealthEast Medical Research Institute, St. Paul, Minn. More than 90% of 39 patients who took at least 400 IU of vitamin D still had serum vitamin D levels below 30 nanograms per mL.

But there was a significant difference overall in the mean serum vitamin D levels between patients who took at least 400 IU of vitamin D and those who took 400 IU of vitamin D supplementation or less (16.4 ng/mL vs. 11.9 ng/mL).

Patients who took at least 400 IU of vitamin D as a daily supplement were significantly less likely to have vitamin D levels in the lowest cutoff group—less than 9 ng/mL—than were patients who took less than 400 IU of vitamin D daily.

The mean vitamin D levels were not significantly different based on age, gender, or use of an osteoporosis medication.

The mean serum 25-hydroxyvitamin D [25(OH)D] level was 14.1 ng/mL among the 61 women in the study, and 14.3 ng/mL among the 17 men. All the patients were aged 50 years or older, all except one were white, and were hospitalized with a fracture between August 1, 2001 and January 31, 2002.

Almost all (97%) of the patients had hip fractures, and 10 (12%) of them were taking an osteoporosis medication prior to their hospital admissions. The investigators excluded patients with high-impact trauma fractures and metastatic cancer diagnoses.

A total of 14 patients (18%) were taking vitamin D only, while 36 (46%) reported taking a multivitamin only and 39 (50%) reported taking vitamin D and/or multivitamins. The study was limited by its small size, lack of ethnic minorities, and possible lack of generalizability to other populations, Dr. Simonelli and her colleagues wrote.

“Half of the patients had little or no vitamin D supplementation,” Dr. Simonelli noted.

Dr. Simonelli received research support from Merck & Co. for this study.

WASHINGTON — A whopping 97% of 78 patients hospitalized for minimal trauma fractures had vitamin D levels of less than 30 ng/mL, Christine Simonelli, M.D., said at an international symposium sponsored by the National Osteoporosis Foundation.

Even the patients who took at least 400 IU of vitamin D had inadequate vitamin D levels, added Dr. Simonelli of HealthEast Medical Research Institute, St. Paul, Minn. More than 90% of 39 patients who took at least 400 IU of vitamin D still had serum vitamin D levels below 30 nanograms per mL.

But there was a significant difference overall in the mean serum vitamin D levels between patients who took at least 400 IU of vitamin D and those who took 400 IU of vitamin D supplementation or less (16.4 ng/mL vs. 11.9 ng/mL).

Patients who took at least 400 IU of vitamin D as a daily supplement were significantly less likely to have vitamin D levels in the lowest cutoff group—less than 9 ng/mL—than were patients who took less than 400 IU of vitamin D daily.

The mean vitamin D levels were not significantly different based on age, gender, or use of an osteoporosis medication.

The mean serum 25-hydroxyvitamin D [25(OH)D] level was 14.1 ng/mL among the 61 women in the study, and 14.3 ng/mL among the 17 men. All the patients were aged 50 years or older, all except one were white, and were hospitalized with a fracture between August 1, 2001 and January 31, 2002.

Almost all (97%) of the patients had hip fractures, and 10 (12%) of them were taking an osteoporosis medication prior to their hospital admissions. The investigators excluded patients with high-impact trauma fractures and metastatic cancer diagnoses.

A total of 14 patients (18%) were taking vitamin D only, while 36 (46%) reported taking a multivitamin only and 39 (50%) reported taking vitamin D and/or multivitamins. The study was limited by its small size, lack of ethnic minorities, and possible lack of generalizability to other populations, Dr. Simonelli and her colleagues wrote.

“Half of the patients had little or no vitamin D supplementation,” Dr. Simonelli noted.

Dr. Simonelli received research support from Merck & Co. for this study.

WASHINGTON — A whopping 97% of 78 patients hospitalized for minimal trauma fractures had vitamin D levels of less than 30 ng/mL, Christine Simonelli, M.D., said at an international symposium sponsored by the National Osteoporosis Foundation.

Even the patients who took at least 400 IU of vitamin D had inadequate vitamin D levels, added Dr. Simonelli of HealthEast Medical Research Institute, St. Paul, Minn. More than 90% of 39 patients who took at least 400 IU of vitamin D still had serum vitamin D levels below 30 nanograms per mL.

But there was a significant difference overall in the mean serum vitamin D levels between patients who took at least 400 IU of vitamin D and those who took 400 IU of vitamin D supplementation or less (16.4 ng/mL vs. 11.9 ng/mL).

Patients who took at least 400 IU of vitamin D as a daily supplement were significantly less likely to have vitamin D levels in the lowest cutoff group—less than 9 ng/mL—than were patients who took less than 400 IU of vitamin D daily.

The mean vitamin D levels were not significantly different based on age, gender, or use of an osteoporosis medication.

The mean serum 25-hydroxyvitamin D [25(OH)D] level was 14.1 ng/mL among the 61 women in the study, and 14.3 ng/mL among the 17 men. All the patients were aged 50 years or older, all except one were white, and were hospitalized with a fracture between August 1, 2001 and January 31, 2002.

Almost all (97%) of the patients had hip fractures, and 10 (12%) of them were taking an osteoporosis medication prior to their hospital admissions. The investigators excluded patients with high-impact trauma fractures and metastatic cancer diagnoses.

A total of 14 patients (18%) were taking vitamin D only, while 36 (46%) reported taking a multivitamin only and 39 (50%) reported taking vitamin D and/or multivitamins. The study was limited by its small size, lack of ethnic minorities, and possible lack of generalizability to other populations, Dr. Simonelli and her colleagues wrote.

“Half of the patients had little or no vitamin D supplementation,” Dr. Simonelli noted.

Dr. Simonelli received research support from Merck & Co. for this study.

Early insertion of tympanostomy tubes during the first 3 years of life did not significantly improve the majority of developmental outcomes at age 6, compared with later insertion, in children with persistent otitis media with effusion, said Jack L. Paradise, M.D., of the University of Pittsburgh, and his colleagues.

In a randomized clinical trial of children with persistent effusion who were 61 days to 3 years old, 201 children received tubes promptly (early-treatment group) and 194 received tubes 6 months later in cases of persistent bilateral effusion and 9 months later for unilateral effusion (delayed-treatment group). The children were enrolled in the study as healthy infants aged 2–61 days, and their middle-ear status was monitored regularly from the time of their enrollment.

Abnormal hearing was diagnosed while effusion was present in approximately 75% of those with bilateral effusion and in approximately 50% of the children with unilateral effusion prior to the insertion of tubes (N. Engl. J. Med. 2005;353:576–86).

At 6 years, unilateral effusion was present in 15 children (7%) in the early-treatment group and 20 children (10%) in the delayed-treatment group, and bilateral effusion was present in 7 children (3%) in the early-treatment group and 3 children (2%) in the delayed-treatment group.

There were no significant differences in the mean scores between the early- and delayed-treatment groups on most assessment tests at 6 years, including the Wechsler Intelligence Scale for Children (scores of 98 for both groups) and the Percentage of Consonants Correct-Revised test (scores of 96 for both groups).

The only significant difference in outcome at 6 years was a higher mean score on the Nonword Repetition Task in the early-treatment group, compared with the delayed-treatment group (76 vs. 74).

These data support and extend results from a previous study by Dr. Paradise and his colleagues in which early insertion of tubes did not improve developmental outcomes at ages 3 or 4 years.

Early insertion of tympanostomy tubes during the first 3 years of life did not significantly improve the majority of developmental outcomes at age 6, compared with later insertion, in children with persistent otitis media with effusion, said Jack L. Paradise, M.D., of the University of Pittsburgh, and his colleagues.

In a randomized clinical trial of children with persistent effusion who were 61 days to 3 years old, 201 children received tubes promptly (early-treatment group) and 194 received tubes 6 months later in cases of persistent bilateral effusion and 9 months later for unilateral effusion (delayed-treatment group). The children were enrolled in the study as healthy infants aged 2–61 days, and their middle-ear status was monitored regularly from the time of their enrollment.

Abnormal hearing was diagnosed while effusion was present in approximately 75% of those with bilateral effusion and in approximately 50% of the children with unilateral effusion prior to the insertion of tubes (N. Engl. J. Med. 2005;353:576–86).

At 6 years, unilateral effusion was present in 15 children (7%) in the early-treatment group and 20 children (10%) in the delayed-treatment group, and bilateral effusion was present in 7 children (3%) in the early-treatment group and 3 children (2%) in the delayed-treatment group.

There were no significant differences in the mean scores between the early- and delayed-treatment groups on most assessment tests at 6 years, including the Wechsler Intelligence Scale for Children (scores of 98 for both groups) and the Percentage of Consonants Correct-Revised test (scores of 96 for both groups).

The only significant difference in outcome at 6 years was a higher mean score on the Nonword Repetition Task in the early-treatment group, compared with the delayed-treatment group (76 vs. 74).

These data support and extend results from a previous study by Dr. Paradise and his colleagues in which early insertion of tubes did not improve developmental outcomes at ages 3 or 4 years.

Early insertion of tympanostomy tubes during the first 3 years of life did not significantly improve the majority of developmental outcomes at age 6, compared with later insertion, in children with persistent otitis media with effusion, said Jack L. Paradise, M.D., of the University of Pittsburgh, and his colleagues.

In a randomized clinical trial of children with persistent effusion who were 61 days to 3 years old, 201 children received tubes promptly (early-treatment group) and 194 received tubes 6 months later in cases of persistent bilateral effusion and 9 months later for unilateral effusion (delayed-treatment group). The children were enrolled in the study as healthy infants aged 2–61 days, and their middle-ear status was monitored regularly from the time of their enrollment.

Abnormal hearing was diagnosed while effusion was present in approximately 75% of those with bilateral effusion and in approximately 50% of the children with unilateral effusion prior to the insertion of tubes (N. Engl. J. Med. 2005;353:576–86).

At 6 years, unilateral effusion was present in 15 children (7%) in the early-treatment group and 20 children (10%) in the delayed-treatment group, and bilateral effusion was present in 7 children (3%) in the early-treatment group and 3 children (2%) in the delayed-treatment group.

There were no significant differences in the mean scores between the early- and delayed-treatment groups on most assessment tests at 6 years, including the Wechsler Intelligence Scale for Children (scores of 98 for both groups) and the Percentage of Consonants Correct-Revised test (scores of 96 for both groups).

The only significant difference in outcome at 6 years was a higher mean score on the Nonword Repetition Task in the early-treatment group, compared with the delayed-treatment group (76 vs. 74).

These data support and extend results from a previous study by Dr. Paradise and his colleagues in which early insertion of tubes did not improve developmental outcomes at ages 3 or 4 years.

Some tympanostomy tubes are going to cause trouble, for reasons that include water precaution issues, otorrhea, blocked tubes, development of granulation tissue, and extrusion problems.

In the first place, the tubes serve as pressure equalizers in children with structural or functional eustachian tube dysfunction, according to Benjamin Cable, M.D., chief of pediatric otolaryngology at Tripler Army Medical Center in Honolulu.

Overall, children with tubes suffer an average of 1.5 episodes of otorrhea per year that the tubes are in place.

Short-acting tubes remain in place for 6–18 months, with an average placement time of 13 months.

Long-acting tubes remain in place for at least 17 months, and may remain indefinitely, so there is plenty of time for complications to develop.

Despite the potential problems, consider tubes for children who experience bilateral effusion for 3 months or have three episodes of acute otitis media in 6 months or 4 episodes in 12 months, Dr. Cable said in an interview.

Stress the importance of being careful in the water, but ear plugs are not particularly helpful, Dr. Cable said. “The real truth is that there is very little evidence supporting the use of ear plugs for water exposure.”

He made two important points: First, the opening of an ear tube is so small that a drop of water would not penetrate due to surface tension. If children swim on the surface, and do not dive well below the water, there is actually little chance of water penetrating the tubes. Second, ear plugs often do not create tight fits within the ear canal.

Otorrhea can occur due to nasopharyngeal pathogens or external auditory canal pathogens. Children who go without treatment of otorrhea tend to have prolonged drainage, Dr. Cable said. “This is not only a problem for the skin of the external canal, but it is often a reason children are sent home from day care, preschool, or school.”

First-line therapy should be ototopical drops in the ear canal, which have demonstrated effectiveness and minimal side effects.

Oral antibiotics are the second-line therapy, and in refractory cases, culture-directed therapy is key, Dr. Cable noted. Drops or oral therapy should be given for 7–10 days, but intravenous therapy may take up to 6 weeks and include home regimens.

Acute posttympanostomy otorrhea is a common complication. However, despite the presence of elevated gastric enzymes in cases of middle ear effusion, gastric reflux has not been shown to play a significant role in acute posttympanostomy otorrhea.

For example, measurable pepsinogen concentrations were below the normal reference ranges in a recent prospective study of 24 children aged 2–16 years (Otolaryngol. Head Neck Surg. 2005;132:523–6).

Tube removal is an option for severe cases of otorrhea. “Most often, tubes that require removal are ones that have become blocked with dried otorrhea or blood,” Dr. Cable said. If drops are unable to loosen the debris, the tubes can be removed and replaced in a slightly different location.

Tympanostomy tubes can become blocked by wax, blood, discharge from otorrhea, or even a foreign body. Some blockages can be opened with topical medications or by physically cleaning out the wax, blood, or discharge.

Granulation tissue must be treated with steroid-containing medication. “New ototopical drops now often contain a combination antibiotic and steroid, Ciprodex, for instance,” Dr. Cable said.

“If this is not available, steroid drops made for ophthalmic use can be used in the ear.”

Autoextrusion occurs in 95% of cases of short-acting tubes. Standard tubes last from 6–18 months with a mean of 13 months, and tubes that last longer than 2 years are considered “retained.”

“We know that the longer the tubes are in place, the less likely it is that the small perforation will heal after extrusion,” Dr. Cable explained. “We used to think that happened at 2 years, but the evidence is now pointing more solidly at longer than 3 years, and most surgeons will recommend removal somewhere between 2 and 3 years.”

Perforation closure occurs in approximately 97% of short-acting tubes and 80% of long-acting tubes.

Looking ahead to the future of tympanostomy tubes, a large amount of research energy is currently being aimed at materials that resist bacterial colonization, in response to concerns that bacteria set up a biofilm on the synthetic material, Dr. Cable said.

“My current first choice for ear tube placement is a standard version of the tube called the Armstrong tube,” he said. “I make this choice based on the ease of placement and the angle of the tube, which allows it to sit in such a way that the future examiner can look directly into the lumen of the tube.”

However, there are many tubes on the market, and many good choices available, he noted.

This tube is in the classic position with dried otorrhea in the center.

This tube is totally blocked with fleshy, shiny granulation tissue.

A “perforation” or hole did not heal after the tube extruded. Photos courtesy Dr. Benjamin Cable

Some tympanostomy tubes are going to cause trouble, for reasons that include water precaution issues, otorrhea, blocked tubes, development of granulation tissue, and extrusion problems.

In the first place, the tubes serve as pressure equalizers in children with structural or functional eustachian tube dysfunction, according to Benjamin Cable, M.D., chief of pediatric otolaryngology at Tripler Army Medical Center in Honolulu.

Overall, children with tubes suffer an average of 1.5 episodes of otorrhea per year that the tubes are in place.

Short-acting tubes remain in place for 6–18 months, with an average placement time of 13 months.

Long-acting tubes remain in place for at least 17 months, and may remain indefinitely, so there is plenty of time for complications to develop.

Despite the potential problems, consider tubes for children who experience bilateral effusion for 3 months or have three episodes of acute otitis media in 6 months or 4 episodes in 12 months, Dr. Cable said in an interview.

Stress the importance of being careful in the water, but ear plugs are not particularly helpful, Dr. Cable said. “The real truth is that there is very little evidence supporting the use of ear plugs for water exposure.”

He made two important points: First, the opening of an ear tube is so small that a drop of water would not penetrate due to surface tension. If children swim on the surface, and do not dive well below the water, there is actually little chance of water penetrating the tubes. Second, ear plugs often do not create tight fits within the ear canal.

Otorrhea can occur due to nasopharyngeal pathogens or external auditory canal pathogens. Children who go without treatment of otorrhea tend to have prolonged drainage, Dr. Cable said. “This is not only a problem for the skin of the external canal, but it is often a reason children are sent home from day care, preschool, or school.”

First-line therapy should be ototopical drops in the ear canal, which have demonstrated effectiveness and minimal side effects.

Oral antibiotics are the second-line therapy, and in refractory cases, culture-directed therapy is key, Dr. Cable noted. Drops or oral therapy should be given for 7–10 days, but intravenous therapy may take up to 6 weeks and include home regimens.

Acute posttympanostomy otorrhea is a common complication. However, despite the presence of elevated gastric enzymes in cases of middle ear effusion, gastric reflux has not been shown to play a significant role in acute posttympanostomy otorrhea.

For example, measurable pepsinogen concentrations were below the normal reference ranges in a recent prospective study of 24 children aged 2–16 years (Otolaryngol. Head Neck Surg. 2005;132:523–6).

Tube removal is an option for severe cases of otorrhea. “Most often, tubes that require removal are ones that have become blocked with dried otorrhea or blood,” Dr. Cable said. If drops are unable to loosen the debris, the tubes can be removed and replaced in a slightly different location.

Tympanostomy tubes can become blocked by wax, blood, discharge from otorrhea, or even a foreign body. Some blockages can be opened with topical medications or by physically cleaning out the wax, blood, or discharge.

Granulation tissue must be treated with steroid-containing medication. “New ototopical drops now often contain a combination antibiotic and steroid, Ciprodex, for instance,” Dr. Cable said.

“If this is not available, steroid drops made for ophthalmic use can be used in the ear.”

Autoextrusion occurs in 95% of cases of short-acting tubes. Standard tubes last from 6–18 months with a mean of 13 months, and tubes that last longer than 2 years are considered “retained.”

“We know that the longer the tubes are in place, the less likely it is that the small perforation will heal after extrusion,” Dr. Cable explained. “We used to think that happened at 2 years, but the evidence is now pointing more solidly at longer than 3 years, and most surgeons will recommend removal somewhere between 2 and 3 years.”

Perforation closure occurs in approximately 97% of short-acting tubes and 80% of long-acting tubes.

Looking ahead to the future of tympanostomy tubes, a large amount of research energy is currently being aimed at materials that resist bacterial colonization, in response to concerns that bacteria set up a biofilm on the synthetic material, Dr. Cable said.

“My current first choice for ear tube placement is a standard version of the tube called the Armstrong tube,” he said. “I make this choice based on the ease of placement and the angle of the tube, which allows it to sit in such a way that the future examiner can look directly into the lumen of the tube.”

However, there are many tubes on the market, and many good choices available, he noted.

This tube is in the classic position with dried otorrhea in the center.

This tube is totally blocked with fleshy, shiny granulation tissue.

A “perforation” or hole did not heal after the tube extruded. Photos courtesy Dr. Benjamin Cable

Some tympanostomy tubes are going to cause trouble, for reasons that include water precaution issues, otorrhea, blocked tubes, development of granulation tissue, and extrusion problems.

In the first place, the tubes serve as pressure equalizers in children with structural or functional eustachian tube dysfunction, according to Benjamin Cable, M.D., chief of pediatric otolaryngology at Tripler Army Medical Center in Honolulu.

Overall, children with tubes suffer an average of 1.5 episodes of otorrhea per year that the tubes are in place.

Short-acting tubes remain in place for 6–18 months, with an average placement time of 13 months.

Long-acting tubes remain in place for at least 17 months, and may remain indefinitely, so there is plenty of time for complications to develop.

Despite the potential problems, consider tubes for children who experience bilateral effusion for 3 months or have three episodes of acute otitis media in 6 months or 4 episodes in 12 months, Dr. Cable said in an interview.

Stress the importance of being careful in the water, but ear plugs are not particularly helpful, Dr. Cable said. “The real truth is that there is very little evidence supporting the use of ear plugs for water exposure.”

He made two important points: First, the opening of an ear tube is so small that a drop of water would not penetrate due to surface tension. If children swim on the surface, and do not dive well below the water, there is actually little chance of water penetrating the tubes. Second, ear plugs often do not create tight fits within the ear canal.

Otorrhea can occur due to nasopharyngeal pathogens or external auditory canal pathogens. Children who go without treatment of otorrhea tend to have prolonged drainage, Dr. Cable said. “This is not only a problem for the skin of the external canal, but it is often a reason children are sent home from day care, preschool, or school.”

First-line therapy should be ototopical drops in the ear canal, which have demonstrated effectiveness and minimal side effects.

Oral antibiotics are the second-line therapy, and in refractory cases, culture-directed therapy is key, Dr. Cable noted. Drops or oral therapy should be given for 7–10 days, but intravenous therapy may take up to 6 weeks and include home regimens.

Acute posttympanostomy otorrhea is a common complication. However, despite the presence of elevated gastric enzymes in cases of middle ear effusion, gastric reflux has not been shown to play a significant role in acute posttympanostomy otorrhea.

For example, measurable pepsinogen concentrations were below the normal reference ranges in a recent prospective study of 24 children aged 2–16 years (Otolaryngol. Head Neck Surg. 2005;132:523–6).

Tube removal is an option for severe cases of otorrhea. “Most often, tubes that require removal are ones that have become blocked with dried otorrhea or blood,” Dr. Cable said. If drops are unable to loosen the debris, the tubes can be removed and replaced in a slightly different location.

Tympanostomy tubes can become blocked by wax, blood, discharge from otorrhea, or even a foreign body. Some blockages can be opened with topical medications or by physically cleaning out the wax, blood, or discharge.

Granulation tissue must be treated with steroid-containing medication. “New ototopical drops now often contain a combination antibiotic and steroid, Ciprodex, for instance,” Dr. Cable said.

“If this is not available, steroid drops made for ophthalmic use can be used in the ear.”

Autoextrusion occurs in 95% of cases of short-acting tubes. Standard tubes last from 6–18 months with a mean of 13 months, and tubes that last longer than 2 years are considered “retained.”

“We know that the longer the tubes are in place, the less likely it is that the small perforation will heal after extrusion,” Dr. Cable explained. “We used to think that happened at 2 years, but the evidence is now pointing more solidly at longer than 3 years, and most surgeons will recommend removal somewhere between 2 and 3 years.”

Perforation closure occurs in approximately 97% of short-acting tubes and 80% of long-acting tubes.

Looking ahead to the future of tympanostomy tubes, a large amount of research energy is currently being aimed at materials that resist bacterial colonization, in response to concerns that bacteria set up a biofilm on the synthetic material, Dr. Cable said.

“My current first choice for ear tube placement is a standard version of the tube called the Armstrong tube,” he said. “I make this choice based on the ease of placement and the angle of the tube, which allows it to sit in such a way that the future examiner can look directly into the lumen of the tube.”

However, there are many tubes on the market, and many good choices available, he noted.

This tube is in the classic position with dried otorrhea in the center.

This tube is totally blocked with fleshy, shiny granulation tissue.

A “perforation” or hole did not heal after the tube extruded. Photos courtesy Dr. Benjamin Cable

Four cases of Eastern Equine Encephalitis were confirmed in Massachusetts as of late September, and two—including one in a 5-year-old child—have been fatal, according to the Massachusetts Department of Public Health.

Five cases—four adults and one 4-year-old child—were confirmed in New Hampshire, according to New Hampshire's Department of Health and Human Services. One adult case, in a 20-year-old woman, has proved fatal.

Although Eastern Equine Encephalitis (EEE) is rare, it is a serious illness. The disease spreads to humans through a bite from an infected mosquito. Birds are the original source of infection, and mosquitoes can transmit the infection to horses, other animals, and humans after biting infected birds.

“We are advising people to limit their dusk and dawn activities,” said Elizabeth A. Talbot, M.D., deputy state epidemiologist of New Hampshire, in an interview. The department also has advised schools and day care centers to drain standing water on their property and encouraged parents to use insect repellent with DEET on children who are involved in outdoor activities after school. “It may be appropriate to spray to kill mosquitoes in some population-dense areas with high mosquito activity,” Dr. Talbot said.

Since there is no specific treatment for EEE, patients are treated with standard supportive care. Symptoms of EEE generally occur 4–10 days after being bitten by an infected mosquito. People at increased risk for disease include children younger than 15 years and adults older than age 50 years, according to the Centers for Disease Control and Prevention.

The disease can cause congestion of blood vessels and changes in nerve cells in all major parts of the brain. The symptoms include headache, sore throat, and mild flulike illness.

A sudden spike in fever, along with a headache and stiff neck, can be followed rapidly by a seizure or coma. Many patients who suffer seizures or comas experience permanent brain damage.

Four cases of Eastern Equine Encephalitis were confirmed in Massachusetts as of late September, and two—including one in a 5-year-old child—have been fatal, according to the Massachusetts Department of Public Health.

Five cases—four adults and one 4-year-old child—were confirmed in New Hampshire, according to New Hampshire's Department of Health and Human Services. One adult case, in a 20-year-old woman, has proved fatal.

Although Eastern Equine Encephalitis (EEE) is rare, it is a serious illness. The disease spreads to humans through a bite from an infected mosquito. Birds are the original source of infection, and mosquitoes can transmit the infection to horses, other animals, and humans after biting infected birds.

“We are advising people to limit their dusk and dawn activities,” said Elizabeth A. Talbot, M.D., deputy state epidemiologist of New Hampshire, in an interview. The department also has advised schools and day care centers to drain standing water on their property and encouraged parents to use insect repellent with DEET on children who are involved in outdoor activities after school. “It may be appropriate to spray to kill mosquitoes in some population-dense areas with high mosquito activity,” Dr. Talbot said.

Since there is no specific treatment for EEE, patients are treated with standard supportive care. Symptoms of EEE generally occur 4–10 days after being bitten by an infected mosquito. People at increased risk for disease include children younger than 15 years and adults older than age 50 years, according to the Centers for Disease Control and Prevention.

The disease can cause congestion of blood vessels and changes in nerve cells in all major parts of the brain. The symptoms include headache, sore throat, and mild flulike illness.

A sudden spike in fever, along with a headache and stiff neck, can be followed rapidly by a seizure or coma. Many patients who suffer seizures or comas experience permanent brain damage.

Four cases of Eastern Equine Encephalitis were confirmed in Massachusetts as of late September, and two—including one in a 5-year-old child—have been fatal, according to the Massachusetts Department of Public Health.

Five cases—four adults and one 4-year-old child—were confirmed in New Hampshire, according to New Hampshire's Department of Health and Human Services. One adult case, in a 20-year-old woman, has proved fatal.

Although Eastern Equine Encephalitis (EEE) is rare, it is a serious illness. The disease spreads to humans through a bite from an infected mosquito. Birds are the original source of infection, and mosquitoes can transmit the infection to horses, other animals, and humans after biting infected birds.

“We are advising people to limit their dusk and dawn activities,” said Elizabeth A. Talbot, M.D., deputy state epidemiologist of New Hampshire, in an interview. The department also has advised schools and day care centers to drain standing water on their property and encouraged parents to use insect repellent with DEET on children who are involved in outdoor activities after school. “It may be appropriate to spray to kill mosquitoes in some population-dense areas with high mosquito activity,” Dr. Talbot said.

Since there is no specific treatment for EEE, patients are treated with standard supportive care. Symptoms of EEE generally occur 4–10 days after being bitten by an infected mosquito. People at increased risk for disease include children younger than 15 years and adults older than age 50 years, according to the Centers for Disease Control and Prevention.

The disease can cause congestion of blood vessels and changes in nerve cells in all major parts of the brain. The symptoms include headache, sore throat, and mild flulike illness.

A sudden spike in fever, along with a headache and stiff neck, can be followed rapidly by a seizure or coma. Many patients who suffer seizures or comas experience permanent brain damage.

WASHINGTON — Doctors, get your flu shots.

Get vaccinated for your patients, do it for yourselves, “do it in droves, just do it,” William Schaffner, M.D., of the National Foundation for Infectious Diseases, said at a press conference.

Julie L. Gerberding, M.D., director of the Centers for Disease Control and Prevention (CDC), stressed the importance of influenza vaccination for everyone.

“We can never predict what the season will look like, when it will start, or how severe it will be,” she said. “We want to emphasize the one thing we know for sure, which is that flu vaccine saves lives, and it is the very best way to prevent flu.”

“This year, we want to make sure that we get vaccine to the people who need it the most, first,” Dr. Gerberding said. “That's why we are recommending that those people who are in high-priority groups get vaccinated now.”

The following groups should receive the trivalent inactivated influenza vaccine in this order, the CDC recommended:

▸ People aged 65 years and older with comorbid conditions, such as heart disease, asthma, diabetes, HIV, and neuromuscular conditions that affect the respiratory system, such as spinal cord injuries.

▸ Long-term care residents.

▸ People aged 2–64 years with comorbid conditions.

▸ People aged 65 years and older without comorbid conditions.

▸ Children aged 6–23 months.

▸ Pregnant women.

The following groups also were designated as priority; however, they may be vaccinated with trivalent inactivated influenza vaccine or the live attenuated influenza vaccine:

▸ Health care workers providing direct patient care.

▸ Caregivers and household contacts of children younger than 6 months or of someone who is severely immunocompromised.

After October 24, anyone who wants a flu shot can have one, and doctors should encourage their patients to get vaccinated and schedule clinics and patient visits accordingly.

Among those who should be vaccinated on October 1: all health care workers.

“Every single doctor and nurse in America needs to make getting vaccinated a priority,” said Ardis D. Hoven, M.D., an infectious disease specialist and representative of the American Medical Association.

“Every year, only two of five health care workers received flu vaccination,” said Jeanne Santoli, M.D., of the National Immunization Program at the CDC. “By vaccinating them, we can protect them and the priority patients that they see. FluMist is a great way to protect health care workers and the household contacts of children less than 6 months of age.”

Except for the few people who work with mostly immunocompromised patients, such as HIV patients or transplant patients, data suggest that FluMist is a safe choice for health care workers who meet the criteria of being healthy, not pregnant, and younger than 64 years, she noted.

“This vaccine [FluMist] is not subject to the tiered approach. It can be used at any time, and if we use this vaccine for health care workers, we can spare doses of the flu shot for more people in the priority groups,” she said.

“When health care professionals ignore vaccine recommendations, the risk of transmission increases significantly,” she said. Conversely, studies have shown that vaccination of health care professionals has been associated with fewer deaths among nursing home patients.

Lack of time is the main reason health care workers don't get vaccinated, and making the vaccine conveniently available in the workplace could make a big difference. “Without a scheduled time to get the vaccine, it is easily overlooked, but a few minutes provides a season of protection,” she said.

WASHINGTON — Doctors, get your flu shots.

Get vaccinated for your patients, do it for yourselves, “do it in droves, just do it,” William Schaffner, M.D., of the National Foundation for Infectious Diseases, said at a press conference.

Julie L. Gerberding, M.D., director of the Centers for Disease Control and Prevention (CDC), stressed the importance of influenza vaccination for everyone.

“We can never predict what the season will look like, when it will start, or how severe it will be,” she said. “We want to emphasize the one thing we know for sure, which is that flu vaccine saves lives, and it is the very best way to prevent flu.”

“This year, we want to make sure that we get vaccine to the people who need it the most, first,” Dr. Gerberding said. “That's why we are recommending that those people who are in high-priority groups get vaccinated now.”

The following groups should receive the trivalent inactivated influenza vaccine in this order, the CDC recommended:

▸ People aged 65 years and older with comorbid conditions, such as heart disease, asthma, diabetes, HIV, and neuromuscular conditions that affect the respiratory system, such as spinal cord injuries.

▸ Long-term care residents.

▸ People aged 2–64 years with comorbid conditions.

▸ People aged 65 years and older without comorbid conditions.

▸ Children aged 6–23 months.

▸ Pregnant women.

The following groups also were designated as priority; however, they may be vaccinated with trivalent inactivated influenza vaccine or the live attenuated influenza vaccine:

▸ Health care workers providing direct patient care.

▸ Caregivers and household contacts of children younger than 6 months or of someone who is severely immunocompromised.

After October 24, anyone who wants a flu shot can have one, and doctors should encourage their patients to get vaccinated and schedule clinics and patient visits accordingly.

Among those who should be vaccinated on October 1: all health care workers.

“Every single doctor and nurse in America needs to make getting vaccinated a priority,” said Ardis D. Hoven, M.D., an infectious disease specialist and representative of the American Medical Association.

“Every year, only two of five health care workers received flu vaccination,” said Jeanne Santoli, M.D., of the National Immunization Program at the CDC. “By vaccinating them, we can protect them and the priority patients that they see. FluMist is a great way to protect health care workers and the household contacts of children less than 6 months of age.”

Except for the few people who work with mostly immunocompromised patients, such as HIV patients or transplant patients, data suggest that FluMist is a safe choice for health care workers who meet the criteria of being healthy, not pregnant, and younger than 64 years, she noted.

“This vaccine [FluMist] is not subject to the tiered approach. It can be used at any time, and if we use this vaccine for health care workers, we can spare doses of the flu shot for more people in the priority groups,” she said.

“When health care professionals ignore vaccine recommendations, the risk of transmission increases significantly,” she said. Conversely, studies have shown that vaccination of health care professionals has been associated with fewer deaths among nursing home patients.

Lack of time is the main reason health care workers don't get vaccinated, and making the vaccine conveniently available in the workplace could make a big difference. “Without a scheduled time to get the vaccine, it is easily overlooked, but a few minutes provides a season of protection,” she said.

WASHINGTON — Doctors, get your flu shots.

Get vaccinated for your patients, do it for yourselves, “do it in droves, just do it,” William Schaffner, M.D., of the National Foundation for Infectious Diseases, said at a press conference.

Julie L. Gerberding, M.D., director of the Centers for Disease Control and Prevention (CDC), stressed the importance of influenza vaccination for everyone.

“We can never predict what the season will look like, when it will start, or how severe it will be,” she said. “We want to emphasize the one thing we know for sure, which is that flu vaccine saves lives, and it is the very best way to prevent flu.”

“This year, we want to make sure that we get vaccine to the people who need it the most, first,” Dr. Gerberding said. “That's why we are recommending that those people who are in high-priority groups get vaccinated now.”

The following groups should receive the trivalent inactivated influenza vaccine in this order, the CDC recommended:

▸ People aged 65 years and older with comorbid conditions, such as heart disease, asthma, diabetes, HIV, and neuromuscular conditions that affect the respiratory system, such as spinal cord injuries.

▸ Long-term care residents.

▸ People aged 2–64 years with comorbid conditions.

▸ People aged 65 years and older without comorbid conditions.

▸ Children aged 6–23 months.

▸ Pregnant women.

The following groups also were designated as priority; however, they may be vaccinated with trivalent inactivated influenza vaccine or the live attenuated influenza vaccine:

▸ Health care workers providing direct patient care.

▸ Caregivers and household contacts of children younger than 6 months or of someone who is severely immunocompromised.

After October 24, anyone who wants a flu shot can have one, and doctors should encourage their patients to get vaccinated and schedule clinics and patient visits accordingly.

Among those who should be vaccinated on October 1: all health care workers.

“Every single doctor and nurse in America needs to make getting vaccinated a priority,” said Ardis D. Hoven, M.D., an infectious disease specialist and representative of the American Medical Association.

“Every year, only two of five health care workers received flu vaccination,” said Jeanne Santoli, M.D., of the National Immunization Program at the CDC. “By vaccinating them, we can protect them and the priority patients that they see. FluMist is a great way to protect health care workers and the household contacts of children less than 6 months of age.”

Except for the few people who work with mostly immunocompromised patients, such as HIV patients or transplant patients, data suggest that FluMist is a safe choice for health care workers who meet the criteria of being healthy, not pregnant, and younger than 64 years, she noted.

“This vaccine [FluMist] is not subject to the tiered approach. It can be used at any time, and if we use this vaccine for health care workers, we can spare doses of the flu shot for more people in the priority groups,” she said.

“When health care professionals ignore vaccine recommendations, the risk of transmission increases significantly,” she said. Conversely, studies have shown that vaccination of health care professionals has been associated with fewer deaths among nursing home patients.

Lack of time is the main reason health care workers don't get vaccinated, and making the vaccine conveniently available in the workplace could make a big difference. “Without a scheduled time to get the vaccine, it is easily overlooked, but a few minutes provides a season of protection,” she said.

A 4-month-old boy with fatal pneumonia transmitted Panton-Valentine leukocidin-producing Staphylococcus aureus to a physician who had attempted to resuscitate him.

This case represents the first reported incident of Panton-Valentine leukocidin- producing S. aureus transmission during resuscitation, said Martin Chalumeau, M.D., of the Hôpital Saint-Vincent de Paul, Paris, and his colleagues (Clin. Infect. Dis. 2005;41:e29–30).

The resuscitation occurred in the general pediatric ward, when the child went into cardiac arrest while being examined by a physician. None of the health care personnel involved in the resuscitation efforts was wearing a face mask or gloves.

Necroscopy results revealed right lobar pneumonia, a necrotizing hemorrhage of the right lung and half of the left lung, and a tracheal aspirate culture that yielded methicillin-susceptible S. aureus (MSSA). The child had presented with 3 days of coughing and 1 day of fever, and had a normal chest radiogram. He developed progressive respiratory failure within 12 hours of hospital admission.

Five days after the incident, the physician who performed the oral intubation on the child had developed furuncles on the fingers and face, and MSSA was found in cultures from the skin lesions. In addition, MSSA was found in cultures collected from 5 of the 15 health care workers who were involved in the resuscitation. The presence of Panton-Valentine leukocidin, a cytotoxin associated with tissue necrosis and leukocyte destruction, was confirmed in the child and the infected physician, but not in the other health care workers.

This incident emphasizes the importance of protecting health care workers against infection, even in general care wards.

A 4-month-old boy with fatal pneumonia transmitted Panton-Valentine leukocidin-producing Staphylococcus aureus to a physician who had attempted to resuscitate him.

This case represents the first reported incident of Panton-Valentine leukocidin- producing S. aureus transmission during resuscitation, said Martin Chalumeau, M.D., of the Hôpital Saint-Vincent de Paul, Paris, and his colleagues (Clin. Infect. Dis. 2005;41:e29–30).

The resuscitation occurred in the general pediatric ward, when the child went into cardiac arrest while being examined by a physician. None of the health care personnel involved in the resuscitation efforts was wearing a face mask or gloves.

Necroscopy results revealed right lobar pneumonia, a necrotizing hemorrhage of the right lung and half of the left lung, and a tracheal aspirate culture that yielded methicillin-susceptible S. aureus (MSSA). The child had presented with 3 days of coughing and 1 day of fever, and had a normal chest radiogram. He developed progressive respiratory failure within 12 hours of hospital admission.

Five days after the incident, the physician who performed the oral intubation on the child had developed furuncles on the fingers and face, and MSSA was found in cultures from the skin lesions. In addition, MSSA was found in cultures collected from 5 of the 15 health care workers who were involved in the resuscitation. The presence of Panton-Valentine leukocidin, a cytotoxin associated with tissue necrosis and leukocyte destruction, was confirmed in the child and the infected physician, but not in the other health care workers.

This incident emphasizes the importance of protecting health care workers against infection, even in general care wards.

A 4-month-old boy with fatal pneumonia transmitted Panton-Valentine leukocidin-producing Staphylococcus aureus to a physician who had attempted to resuscitate him.

This case represents the first reported incident of Panton-Valentine leukocidin- producing S. aureus transmission during resuscitation, said Martin Chalumeau, M.D., of the Hôpital Saint-Vincent de Paul, Paris, and his colleagues (Clin. Infect. Dis. 2005;41:e29–30).

The resuscitation occurred in the general pediatric ward, when the child went into cardiac arrest while being examined by a physician. None of the health care personnel involved in the resuscitation efforts was wearing a face mask or gloves.

Necroscopy results revealed right lobar pneumonia, a necrotizing hemorrhage of the right lung and half of the left lung, and a tracheal aspirate culture that yielded methicillin-susceptible S. aureus (MSSA). The child had presented with 3 days of coughing and 1 day of fever, and had a normal chest radiogram. He developed progressive respiratory failure within 12 hours of hospital admission.

Five days after the incident, the physician who performed the oral intubation on the child had developed furuncles on the fingers and face, and MSSA was found in cultures from the skin lesions. In addition, MSSA was found in cultures collected from 5 of the 15 health care workers who were involved in the resuscitation. The presence of Panton-Valentine leukocidin, a cytotoxin associated with tissue necrosis and leukocyte destruction, was confirmed in the child and the infected physician, but not in the other health care workers.

This incident emphasizes the importance of protecting health care workers against infection, even in general care wards.

Patients in Canada with attention-deficit hyperactivity disorder are now able to obtain Adderall XR.

Sales of the drug, distributed by Shire Pharmaceuticals Group PLC, had been suspended earlier this year in Canada after the release of postmarketing reports of sudden death in 12 children in the United States who had taken the drug between 1999 and 2003.

At Shire's request, Health Canada, that country's drug regulatory agency, convened the New Drug Committee, a three-member panel of experts in pediatric cardiology, pediatric development, and pharmacoepidemiology, to review the suspension of the drug. The committee's recommendation to reinstate Adderall XR, which came in late August, hinged on the adoption of revisions to the Canadian version of the product monograph and to the patient leaflet.

The committee also recommended a Dear Healthcare Professional letter, as well as continuing medical education about sudden death in otherwise healthy children. The product label had been changed in August 2004 to include a warning that patients with underlying heart disease might be at increased risk for sudden death.

Patients in Canada with attention-deficit hyperactivity disorder are now able to obtain Adderall XR.

Sales of the drug, distributed by Shire Pharmaceuticals Group PLC, had been suspended earlier this year in Canada after the release of postmarketing reports of sudden death in 12 children in the United States who had taken the drug between 1999 and 2003.

At Shire's request, Health Canada, that country's drug regulatory agency, convened the New Drug Committee, a three-member panel of experts in pediatric cardiology, pediatric development, and pharmacoepidemiology, to review the suspension of the drug. The committee's recommendation to reinstate Adderall XR, which came in late August, hinged on the adoption of revisions to the Canadian version of the product monograph and to the patient leaflet.

The committee also recommended a Dear Healthcare Professional letter, as well as continuing medical education about sudden death in otherwise healthy children. The product label had been changed in August 2004 to include a warning that patients with underlying heart disease might be at increased risk for sudden death.

Patients in Canada with attention-deficit hyperactivity disorder are now able to obtain Adderall XR.

Sales of the drug, distributed by Shire Pharmaceuticals Group PLC, had been suspended earlier this year in Canada after the release of postmarketing reports of sudden death in 12 children in the United States who had taken the drug between 1999 and 2003.

At Shire's request, Health Canada, that country's drug regulatory agency, convened the New Drug Committee, a three-member panel of experts in pediatric cardiology, pediatric development, and pharmacoepidemiology, to review the suspension of the drug. The committee's recommendation to reinstate Adderall XR, which came in late August, hinged on the adoption of revisions to the Canadian version of the product monograph and to the patient leaflet.

The committee also recommended a Dear Healthcare Professional letter, as well as continuing medical education about sudden death in otherwise healthy children. The product label had been changed in August 2004 to include a warning that patients with underlying heart disease might be at increased risk for sudden death.

BETHESDA, MD. — Drug resistance poses a problem in treating HIV patients, in part because of the virus's high mutation rate, Roy M. Gulick, M.D., said at an annual conference on antimicrobial resistance sponsored by the National Foundation for Infectious Diseases.

Factors affecting HIV drug resistance include the virus itself, the antiretroviral drugs used, and the characteristics of the individual patient. Drug resistance is one of the main reasons why HIV treatments fail, said Dr. Gulick, director of the Cornell HIV Clinical Trials Unit at Weill Medical College of Cornell University, New York.

The goal of antiretroviral therapy (ART) is to suppress the viral load to as low a level as possible for as long as possible, he noted. Due to the high rate of mutation in the HIV virus, viral diversity is extensive. Failure to suppress viral load levels in the presence of antiretroviral drugs leads to the development of a resistant strain, Dr. Gulick explained.

Patient-related factors that can contribute to the development of resistance include the stage of disease, use of other medications, medication adherence, and side effects.

“We used to follow resistance clinically. If someone was taking their drugs, and their viral load went down, but then rose again, if we were sure that they were taking the medication, we assumed that they had developed resistance,” he said. Today, genotypic tests provide viral sequencing of a patient's viral strain, and phenotypic tests can grow the patient's virus in vitro and assess resistance in the presence of the available antiretroviral drugs.

Are resistance tests clinically valuable? Dr. Gulick cited three studies, including one published in the Lancet, in which several hundred patients who had failed drug therapies were randomized to either genotypic or phenotypic drug resistance testing or standard care (Lancet 1999;353:2195–9).

Overall, the patients who fared better in terms of viral load reduction on their new regimens were the ones who had the resistance tests.

“Simply put, resistance tests help clinicians choose active drugs for the next regimen,” Dr. Gulick said. Guidelines from the Department of Health and Human Services recommend resistance tests in the clinical setting in cases of virologic failure, suboptimal virologic suppression, and acute HIV infection.

These tests could be considered in cases of HIV infection before starting ART, but they are generally not recommended for patients more than 4 weeks after ART drug use ends, or when viral load levels are less than 1,000 copies per million.

However, studies of the effectiveness of resistance testing are limited by several factors, including problems with the clinical cutoffs—when the drugs lose activity over time—and questions as to whether the studies had enrolled patients who had failed multiple treatments.

Other studies have shown conflicting results regarding the use of resistance tests, especially for highly resistant patients. “The best resistance tests can't help a patient if they have no drug options to go to,” Dr. Gulick said.

Asked whether he recommends genotypic or phenotypic testing for patients who are just starting antiretroviral therapy or who already have resistance, Dr. Gulick commented that although sufficient clinical evidence is lacking, most experts recommend a genotype test for patients who are treatment naive or have failed their first regimen, when it is relatively easy to figure out what the mutations mean. But in patients who have been through multiple regimens, phenotype is easier to interpret.

“Many people say that if cost is not an issue, they would get both tests, because they tell you different things—particularly in the late stages of infection,” he added.

BETHESDA, MD. — Drug resistance poses a problem in treating HIV patients, in part because of the virus's high mutation rate, Roy M. Gulick, M.D., said at an annual conference on antimicrobial resistance sponsored by the National Foundation for Infectious Diseases.

Factors affecting HIV drug resistance include the virus itself, the antiretroviral drugs used, and the characteristics of the individual patient. Drug resistance is one of the main reasons why HIV treatments fail, said Dr. Gulick, director of the Cornell HIV Clinical Trials Unit at Weill Medical College of Cornell University, New York.

The goal of antiretroviral therapy (ART) is to suppress the viral load to as low a level as possible for as long as possible, he noted. Due to the high rate of mutation in the HIV virus, viral diversity is extensive. Failure to suppress viral load levels in the presence of antiretroviral drugs leads to the development of a resistant strain, Dr. Gulick explained.

Patient-related factors that can contribute to the development of resistance include the stage of disease, use of other medications, medication adherence, and side effects.

“We used to follow resistance clinically. If someone was taking their drugs, and their viral load went down, but then rose again, if we were sure that they were taking the medication, we assumed that they had developed resistance,” he said. Today, genotypic tests provide viral sequencing of a patient's viral strain, and phenotypic tests can grow the patient's virus in vitro and assess resistance in the presence of the available antiretroviral drugs.

Are resistance tests clinically valuable? Dr. Gulick cited three studies, including one published in the Lancet, in which several hundred patients who had failed drug therapies were randomized to either genotypic or phenotypic drug resistance testing or standard care (Lancet 1999;353:2195–9).

Overall, the patients who fared better in terms of viral load reduction on their new regimens were the ones who had the resistance tests.

“Simply put, resistance tests help clinicians choose active drugs for the next regimen,” Dr. Gulick said. Guidelines from the Department of Health and Human Services recommend resistance tests in the clinical setting in cases of virologic failure, suboptimal virologic suppression, and acute HIV infection.

These tests could be considered in cases of HIV infection before starting ART, but they are generally not recommended for patients more than 4 weeks after ART drug use ends, or when viral load levels are less than 1,000 copies per million.

However, studies of the effectiveness of resistance testing are limited by several factors, including problems with the clinical cutoffs—when the drugs lose activity over time—and questions as to whether the studies had enrolled patients who had failed multiple treatments.

Other studies have shown conflicting results regarding the use of resistance tests, especially for highly resistant patients. “The best resistance tests can't help a patient if they have no drug options to go to,” Dr. Gulick said.

Asked whether he recommends genotypic or phenotypic testing for patients who are just starting antiretroviral therapy or who already have resistance, Dr. Gulick commented that although sufficient clinical evidence is lacking, most experts recommend a genotype test for patients who are treatment naive or have failed their first regimen, when it is relatively easy to figure out what the mutations mean. But in patients who have been through multiple regimens, phenotype is easier to interpret.

“Many people say that if cost is not an issue, they would get both tests, because they tell you different things—particularly in the late stages of infection,” he added.

BETHESDA, MD. — Drug resistance poses a problem in treating HIV patients, in part because of the virus's high mutation rate, Roy M. Gulick, M.D., said at an annual conference on antimicrobial resistance sponsored by the National Foundation for Infectious Diseases.

Factors affecting HIV drug resistance include the virus itself, the antiretroviral drugs used, and the characteristics of the individual patient. Drug resistance is one of the main reasons why HIV treatments fail, said Dr. Gulick, director of the Cornell HIV Clinical Trials Unit at Weill Medical College of Cornell University, New York.

The goal of antiretroviral therapy (ART) is to suppress the viral load to as low a level as possible for as long as possible, he noted. Due to the high rate of mutation in the HIV virus, viral diversity is extensive. Failure to suppress viral load levels in the presence of antiretroviral drugs leads to the development of a resistant strain, Dr. Gulick explained.

Patient-related factors that can contribute to the development of resistance include the stage of disease, use of other medications, medication adherence, and side effects.

“We used to follow resistance clinically. If someone was taking their drugs, and their viral load went down, but then rose again, if we were sure that they were taking the medication, we assumed that they had developed resistance,” he said. Today, genotypic tests provide viral sequencing of a patient's viral strain, and phenotypic tests can grow the patient's virus in vitro and assess resistance in the presence of the available antiretroviral drugs.

Are resistance tests clinically valuable? Dr. Gulick cited three studies, including one published in the Lancet, in which several hundred patients who had failed drug therapies were randomized to either genotypic or phenotypic drug resistance testing or standard care (Lancet 1999;353:2195–9).

Overall, the patients who fared better in terms of viral load reduction on their new regimens were the ones who had the resistance tests.

“Simply put, resistance tests help clinicians choose active drugs for the next regimen,” Dr. Gulick said. Guidelines from the Department of Health and Human Services recommend resistance tests in the clinical setting in cases of virologic failure, suboptimal virologic suppression, and acute HIV infection.

These tests could be considered in cases of HIV infection before starting ART, but they are generally not recommended for patients more than 4 weeks after ART drug use ends, or when viral load levels are less than 1,000 copies per million.

However, studies of the effectiveness of resistance testing are limited by several factors, including problems with the clinical cutoffs—when the drugs lose activity over time—and questions as to whether the studies had enrolled patients who had failed multiple treatments.

Other studies have shown conflicting results regarding the use of resistance tests, especially for highly resistant patients. “The best resistance tests can't help a patient if they have no drug options to go to,” Dr. Gulick said.

Asked whether he recommends genotypic or phenotypic testing for patients who are just starting antiretroviral therapy or who already have resistance, Dr. Gulick commented that although sufficient clinical evidence is lacking, most experts recommend a genotype test for patients who are treatment naive or have failed their first regimen, when it is relatively easy to figure out what the mutations mean. But in patients who have been through multiple regimens, phenotype is easier to interpret.

“Many people say that if cost is not an issue, they would get both tests, because they tell you different things—particularly in the late stages of infection,” he added.