A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media

Abstract

PA Tahtinen, MK Laine, P Huovinen, J Jalava, O Ruuskanen, A Ruohola. N Engl J Med. 2011;364(2):116–126 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 …