CompletedPhase 3Phase 4ACTRN12609000691246

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?

Sponsor

NHMRC

Enrollment

330 participants

Start Date

Jan 1, 2002

Study Type

Interventional

Conditions

Acute otitis media in Indigenous children aged 6 months to 6 years

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

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two antibiotics — azithromycin and amoxicillin — for treating ear infections in Aboriginal children aged 6 months to 6 years. The goal is to find out which antibiotic works better for acute middle ear infections in this population.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Australia

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ACTRN12609000691246