Amoxicillin-clavulanate for acute otitis media in small children

January 01, 0001

Amoxicillin-clavulanate for acute otitis media in small children

The efficacy of antimicrobial treatment in children with acute otitis media is controversial. In this randomized, double-blind trial by Finnish investigators, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.

They found: "Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo. The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38) and the need for rescue treatment by 81% (6.8% vs. 33.5%). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group; 8.7% and 3.2% of the children in the respective groups had eczema."

The authors concluded: "Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance."

A key to these study results was using strict criteria for diagnosis of acute otitis media.

For the full abstract, click here.

N Engl J Med 364:116-126, 13 January 2011
© 2011 to the Massachusetts Medical Society
A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media. Paula A. Tähtinen, Miia K. Laine, Pentti Huovinen, Jari Jalava, Olli Ruuskanen, and Aino Ruohola. Correspondence to Dr. Ruohola: [email protected]

Category: H. Ear. Keywords: acute otitis media, children, amoxicillin-clavulanate, diarrhea, eczema, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 1 February 2011

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