Azithromycin versus Amoxicillin for Treatment of Acute otitis media in Aboriginal Children (AATAAC)
In Indigenous children aged 6 months to 6 years with a diagnosis of acute otitis media, does Azithromycin given as a single dose (compared to 7 days of standard dose amoxicillin) result in a reduction in the proportion of children with signs of persistent disease after treatment?
NHMRC
330 participants
Jan 1, 2002
Interventional
Conditions
Summary
The purpose of the study is to determine whether single dose azithromycin is superior to standard therapy (7 days amoxicillin) in resolving acute otitis media in Aboriginal children at high risk of tympanic membrane perforation.
Eligibility
Inclusion Criteria1
- Aboriginal. Betwen age 6 mo and 6 years. New diagnosis of acute otitis media (AOM) without perforation or AOM with perforation. Children willing to attend for follow-up at day 6 to 11, and day 12-21 for children with perforation.
Exclusion Criteria1
- Randomised previously in the same study. Received antibiotics in the previous 7 dyas. Current severe illness requiring intravenous or intramuscualar antibiotics within the next 7 days. Allergy to penicillin or azithromycin. Perforation in affected ear(s) greater than 2%
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Interventions
A single dose of the macrolide antibiotic azithromycin 30mg/kg administered orally. Placebo syrup identical in smell, taste and apprearance was used in a doubel dummy fashion.
Locations(1)
View Full Details on ANZCTR
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ACTRN12609000691246