ACTRN12608000424303.

Trial name or title	Antibiotics for asymptomatic acute otitis media
Methods	Double‐blind, placebo‐controlled randomised clinical trial
Participants	Aboriginal children aged between 6 and 30 months diagnosed with asymptomatic acute otitis media defined as a bulging tympanic membrane without associated symptoms (including ear pain, fever or ear discharge) at the time of diagnosis
Interventions	Azithromycin 30 mg/kg divided into 2 doses or placebo for 7 days
Outcomes	Primary outcome ‐ proportion of children with a bulging tympanic membrane or ear discharge or withdrawn due to complications or side effects at 14 days (all children who are lost to follow‐up are considered clinical failures) Secondary outcomes ‐ (a) proportion of children with unresolved bulging at 7 and 30 days; (b) proportion of children with a bulging tympanic membrane or ear discharge or withdrawn due to complications or side effects at 7, 14 and 30 days (not including children who are lost to follow‐up); (c) proportion of children who develop an illness requiring additional medical treatment at 7, 14 and 30 days; (d) proportion of children who develop an illness requiring cessation of prescribed antibiotics at 30 days; (e) proportion of children who have no improvement in other conditions recorded, like skin sores and rhinosinusitis, at 7, 14 and 30 days; (f) microbiological outcomes including carriage and antibiotic resistance of Streptococcus pneumoniae and Haemophilus influenzae at 7, 14 and 30 days
Starting date	March 2007
Contact information	Menzies School of Health Research, PO Box 41096, Casuarina NT 0811, Australia
Notes	ACTRN12608000424303