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Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized, placebo-controlled trial.

Author(s): van der Veen EL, Rovers MM, Albers FW, Sanders EA, Schilder AG

Affiliation(s): Department of Otorhinolaryngology (KE04.140.5), Wilhelmina Children's Hospital, University Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, Netherlands. e.l.vanderveen@umcutrecht.nl.

Publication date & source: 2007-05, Pediatrics., 119(5):897-904.

OBJECTIVE. The goal was to determine the clinical effectiveness of prolonged outpatient treatment with trimethoprim/sulfamethoxazole for children with chronic active otitis media. METHODS. We performed a randomized, placebo-controlled trial with 101 children (1-12 years of age) with chronic active otitis media (defined as otorrhea for >/=12 weeks). In addition to a short course of steroid and antibiotic eardrops, children were assigned randomly to receive 6 to 12 weeks of orally administered trimethoprim/sulfamethoxazole (18 mg/kg, 2 times per day) or placebo and were monitored for 1 year. RESULTS. At 6 weeks, 28% of children in the trimethoprim/sulfamethoxazole group and 53% of children in the placebo group had otomicroscopic signs of otorrhea. At 12 weeks, these values were 32% and 47%, respectively. At 1 year, the numbers of children with otorrhea were similar in the 2 groups (25% and 20%, respectively). One child in the trimethoprim/sulfamethoxazole group developed a skin rash. Vomiting or diarrhea was reported for 9% of the trimethoprim/sulfamethoxazole group and 2% of the placebo group. Pure-tone hearing levels and health-related quality of life improved during the study but did not differ between the trimethoprim/sulfamethoxazole group and the placebo group. Pseudomonas aeruginosa was the most frequently isolated bacteria in the otorrhea samples from both groups. CONCLUSIONS. A 6- to 12-week course of high-dose, orally administered trimethoprim/sulfamethoxazole therapy is beneficial for children with chronic active otitis media. The treatment effect is most pronounced with the shorter course and disappears if administration of the medication is discontinued.

Page last updated: 2007-05-03

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