PURPOSE OF THE STUDY.
To examine the efficacy of treatment of acute otitis media (AOM) with amoxicillin-clavulanate.
The study included a total of 319 children aged 6 to 35 months with AOM.
The diagnosis of AOM was made with strict criteria, including signs on physical examination and typical symptoms. The subjects were randomly assigned to receive amoxicillin-clavulanate or placebo for 7 days. The primary outcome was the time to treatment failure from the first dose until the end of treatment on visit day 8. Treatment failure was based on the overall condition of the subjects (including adverse events) and otoscopic examination.
Among the subjects who received amoxicillin-clavulanate, treatment failure occurred 18.6% of the time compared with a rate of 44.9% for the subjects who received placebo (P < .001). This difference was already apparent at the first scheduled visit at day 3, at which time 13.7% of the subjects who received amoxicillin-clavulanate, compared with 25.3% of subjects who received placebo, had treatment failure. Amoxicillin-clavulanate reduced the progression to treatment failure by 62% (P < .001) and the need for rescue treatment by 81% (P < .001). Adverse events (primarily diarrhea) were significantly more common in the amoxicillin-clavulanate group than in the placebo group.
Children with AOM (aged 6–35 months) treated for 7 days with amoxicillin-clavulanate had a much lower rate of treatment failure and much lower need for rescue treatment than children treated with placebo. However, the children treated with amoxicillin-clavulanate had more adverse effects.
This article challenges us to rethink an approach to therapy. Some of the reasons for the differences between these results and other studies that have been performed in past years (which have not shown as pronounced an effect of treatment versus placebo) might include the strict criteria for diagnosing AOM, the decision to include all subjects in the trial with AOM irrespective of the severity, and the use of a potent antibiotic. The authors pointed out that, because the treatment group showed improvement as early as day 3, additional investigation might be needed to examine the practice of “watchful waiting.” Another article in the same issue of the journal (Hoberman A, Paradise JL, Rockette HE, et al. N Engl J Med. 2011;364:105–115) reported that among children younger than 2 years with AOM, treatment with amoxicillin-clavulanate for 10 days, relative to placebo, tended to reduce the time to resolution of symptoms and reduced both the overall burden of symptoms and the rate of clinical failure of treatment.
- Copyright © 2011 by the American Academy of Pediatrics