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?

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000691246

Acronym

AATAAC

Enrollment

330

Registered

2009-08-12

Start date

2002-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Months to 6 Years

Healthy volunteers

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%

Outcome results