Published online May 1, 2007
PEDIATRICS Vol. 119 No. 5 May 2007, pp. 897-904 (doi:10.1542/peds.2006-2787)
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ARTICLE

Effectiveness of Trimethoprim/Sulfamethoxazole for Children With Chronic Active Otitis Media: A Randomized, Placebo-Controlled Trial

Erwin L. van der Veen, MDa, Maroeska M. Rovers, PhDa,b,c, Frans W. J. Albers, MD, PhDa, Elisabeth A. M. Sanders, MD, PhDb and Anne G. M. Schilder, MD, PhDa

a Departments of Otorhinolaryngology
b Paediatric Immunology, Wilhelmina Children's Hospital
c Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands

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.

Key Words: chronic suppurative otitis media • children • drug therapy • trimethoprim/sulfamethoxazole combination

Abbreviations: COM—chronic active otitis media • NNT—number needed to treat • RD—rate difference • CI—confidence interval

Accepted Dec 15, 2006.




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