BACKGROUND AND OBJECTIVES: Antimicrobial treatment is effective in the management of acute otitis media (AOM), but approximately half of the children may recover without antimicrobial agents. By identifying patients who may not require antimicrobial treatment for the management of AOM, the use of antimicrobial agents could be substantially reduced. Our aim was to identify subgroups of children with AOM who would benefit most from antimicrobial treatment and children who could be suitable for initial observation.

METHODS: This is a secondary analysis of randomized, double-blind, placebo-controlled trial. Children 6 to 35 months of age with AOM (N = 319) were randomly allocated to receive amoxicillin-clavulanate (40/5.7 mg/kg per day) or placebo for 7 days. Our primary outcome was time until treatment failure.

RESULTS: Treatment failure occurred in 31.7% of all children. Older age (24–35 months) and peaked tympanogram at entry decreased the hazard for treatment failure (hazard ratio, 0.53; 95% confidence interval [CI], 0.29 to 0.96; P = .04; and hazard ratio, 0.43; 95% CI, 0.21 to 0.88; P = .02, respectively). The rate difference for treatment failure between antimicrobial treatment and placebo groups was highest among children with severe bulging of the tympanic membrane (11.1% vs 64.1%; rate difference −53.0%; 95% CI, −73.5% to −32.4%), resulting in a number needed to treat of 1.9.

CONCLUSIONS: Children with severe bulging of the tympanic membrane seem to benefit most from antimicrobial treatment of AOM. On the other hand, children with peaked tympanogram (A and C curves) may be optimal candidates for initial observation