Azithromycin versus Amoxicillin for Treatment of Acute otitis media in Aboriginal Children (AATAAC)

Phase 3

Completed

• Conditions: Acute otitis media in Indigenous children aged 6 months to 6 years; Ear - Other ear disorders

• Registration Number: ACTRN12609000691246
• Lead Sponsor: HMRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 330

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%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical failure: Proportion of children with persistent pain or bulging or middle ear discharge or withdrawn due to complications or side effects. Assessment by health care professionals using video otoscopy and tympanometry and standardised.[day 6 to 11 post commencement of treatment];Clinical failure: Proportion of children with active perforation. Assessment by health care professionals using video otoscopy and tympanometry and standardised.[day 6 to 11 post commencement of treatment]