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Randomised placebo-controlled trial.
Patients were stratified for history of recurrent otitis media and exposure to other children and randomised in blocks of four. The method of allocation concealment was not stated.
Blinding of researchers, parents and caregivers.
Large tertiary hospital in Pittsburgh, USA and associated private clinic.
291 children aged 6–23 months, who had received pneumococcal conjugate vaccine, and scored 3 or more on the Acute Otitis Media Severity of Symptoms scale.
144 infants were assigned to amoxicillin–clavulanate (Augmentin ES), amoxicillin 90 mg/kg (clavulanate 6.4 mg/kg) divided in two daily doses for 10 days and 147 were assigned to placebo.
Primary outcome was time to resolution of symptoms; secondary outcomes were overall efficacy, use of paracetamol and adverse events.
Until days 21–25.
137/144 in treatment versus 145/147 in placebo (compliance achieved in 85%).
Children treated with antibiotics for acute otitis media diagnosed by strict criteria benefited with reduced time to resolution of symptoms; however, treatment resulted in more diarrhoea and rash.
Correspondence to Martin Burton, Consultant Otolaryngologist, Oxford Radcliffe NHS Trust, The West Wing, John Radcliffe Hospital, Oxford OX3 9DU, UK;
Sources of funding Supported by grant 3U01AI066007-02S1 from the National Institute of Allergy and Infectious Diseases.
Sources of funding Supported by the Fellowship Award of the European Society for Paediatric Infectious Diseases (to Dr Ruohola), grants from the Foundation for Paediatric Research and others.
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.