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Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized,
Erwin L van der Veen1, Maroeska M Rovers, Frans W J Albers
1Department of Otorhinolaryngology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands. e.l.vanderveen@umcutrecht.nl
Insights
Prolonged outpatient trimethoprim/sulfamethoxazole treatment effectively reduced otorrhea in children with chronic active otitis media, with benefits most pronounced in shorter treatment courses.
Area of Science:
- Pediatrics
- Otolaryngology
- Infectious Diseases
Background:
- Chronic active otitis media, characterized by persistent otorrhea, affects children and requires effective treatment strategies.
- Outpatient management is preferred for pediatric ear infections when feasible.
Purpose of the Study:
- To evaluate the clinical effectiveness of extended outpatient therapy with trimethoprim/sulfamethoxazole in pediatric patients diagnosed with chronic active otitis media.
Main Methods:
- A randomized, placebo-controlled trial involving 101 children aged 1-12 years with chronic otitis media and otorrhea lasting over 12 weeks.
- Participants received standard care (steroid/antibiotic ear drops) plus either 6-12 weeks of oral trimethoprim/sulfamethoxazole or a placebo, with a one-year follow-up period.
Main Results:
- Trimethoprim/sulfamethoxazole significantly reduced otomicroscopic signs of otorrhea at 6 and 12 weeks compared to placebo.
- Otorrhea rates were similar between groups at one year, suggesting a transient effect.
- Adverse events included a rash in one child and gastrointestinal issues in 9% of the trimethoprim/sulfamethoxazole group.
- Improvements in hearing and quality of life were observed in both groups, with no significant difference between them.
Conclusions:
- A 6-12 week course of high-dose oral trimethoprim/sulfamethoxazole offers clinical benefits for children with chronic active otitis media.
- The therapeutic effect is most evident with shorter treatment durations and diminishes upon discontinuation of the medication.
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 > or =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.