Azithromycin versus placebo in the treatment of asymptomatic acute otitis media in young Aboriginal children : A RCT

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Remote Aboriginal children have the highest rates of severe ear infection reported in the medical literature. At any time, large numbers of children have a bulging eardrum (acute otitis media) but most are completely asymptomatic. In our previous antibiotic study, acute otitis media (AOM) persisted in 50% of children after 1 week of treatment. In terms of clinical success, it didn't make any difference whether azithromycin or amoxicillin was used (although azithromycin seemed to be better at reducing the level of infection). Currently local clinicians are: i) uncertain whether antibiotics make any difference at all; and ii) reluctant to devote resources to case-finding without good evidence of substantial benefit. In this randomised controlled trial, we will determine the benefits of 2 doses of azithromycin given 1 week apart in children with asymptomatic acute otitis media will improve health outcomes. The results of the trial will become the best available evidence to guide the medical management of asymptomatic AOM in high-risk children. We anticipate that it will make an important contribution in the shift toward more effective prevention and management of otitis media in Australian Aboriginal children. It will also have implications for all disadvantaged populations where adverse outcomes are common and compliance with recommended treatment is poor.