RecruitingPhase 3Phase 4ACTRN12608000424303

Antibtiotics for Asymptomatic Acute Otitis Media

A double blind placebo-controlled randomized clinical trial of the use of oral azithromycin in Aboriginal children between 6 months and 30 months of age presenting with asymptomatic acute otitis media without perforation


Sponsor

Menzies School of Health Research

Enrollment

300 participants

Start Date

Mar 31, 2007

Study Type

Interventional

Conditions

Summary

The primary aim of this study is to evaluate whether azithromycin compared with no treatment results in a reduction in the proportion of children with signs of persistent disease 14 days after starting treatment.


Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 30 Monthss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a short course of antibiotics (azithromycin) helps Aboriginal children who have a middle ear infection with no pain or fever — called asymptomatic acute otitis media. Sometimes the eardrum bulges out from fluid buildup even when the child does not seem sick. Researchers want to find out if treating this early with antibiotics helps clear up the problem faster than simply waiting and watching. You may be eligible if: - Your child is an Aboriginal child living in a participating community - Your child is between 6 and 30 months old - Your child has been diagnosed with a bulging eardrum but has no ear pain or fever - You are able to bring your child back to the clinic for follow-up visits at 7, 14, and 28 days - You have given signed informed consent You may NOT be eligible if: - Your child has ear pain or fever along with the ear infection - Your child has had recent ear discharge or perforation (within the last 7 days) - Your child has chronic ear disease with ongoing discharge - Your child was already enrolled in this study before - Your child received antibiotics in the last 7 days (not including ear drops) - Your child has a more serious illness that already needs antibiotics - Your child is allergic to azithromycin - Your child has an immune system problem Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Two doses of 30mg/kg of azithromycin or the placebo will be adminstered a week a apart on Day 0 and Day 7. The mode of administration of the drug will be oral suspension.

Two doses of 30mg/kg of azithromycin or the placebo will be adminstered a week a apart on Day 0 and Day 7. The mode of administration of the drug will be oral suspension.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12608000424303