ACTRN12609000691246
Completed
Phase 3
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?
HMRC0 sites330 target enrollmentAugust 12, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute otitis media in Indigenous children aged 6 months to 6 years
- Sponsor
- HMRC
- Enrollment
- 330
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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%
Outcomes
Primary Outcomes
Not specified
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