CompletedPhase 4ACTRN12612000011886

Antibiotics for bronchiectasis exacerbations in children - The Bronchiectasis Exacerbation Study (Study 1).

A randomised, double blind, placebo controlled trial of Azithromycin versus Amoxycillin-Clavulanic Acid to treat mild to moderate respiratory exacerbations in children with non-Cystic Fibrosis bronchiectasis, Study One.

Sponsor

Qld Children's Medical Research Institute

Enrollment

189 participants

Start Date

Jul 3, 2012

Study Type

Interventional

Conditions

Bronchiectasis

Summary

Our national study aims to improve the management of acute exacerbations of bronchiectasis in children, a lung condition that is common in Indigenous people worldwide, and also occurs in non-Indigenous people. This study aims to discover whether treating acute exacerbations of bronchiectasis with oral antibiotics is effective at resolving the exacerbation more quickly than not treating with antibiotics. The results of this study will impact on national and international guidelines and substantially advance knowledge on exacerbations of childhood bronchiectasis.

Eligibility

Sex: Both males and femalesMax Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This companion study also compares antibiotic treatments for bronchiectasis flare-ups in children under 18, using the same eligibility criteria as the related Bronchiectasis Exacerbation Study 2. Children must have confirmed bronchiectasis with at least 2 flare-ups in the past 18 months. Those with cystic fibrosis, liver problems, recent severe episodes, pseudomonas infection, or allergies to the study antibiotics are excluded.

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

Arm 1: Daily oral Azithromycin 5mg/kg for 14 days Arm 2: Twice daily oral Amoxycillin-Clavulanic Acid 22.5mg/kg for 14 days Arm 3: oral placebo for 14 days These treatments are administered at th

Arm 1: Daily oral Azithromycin 5mg/kg for 14 days Arm 2: Twice daily oral Amoxycillin-Clavulanic Acid 22.5mg/kg for 14 days Arm 3: oral placebo for 14 days These treatments are administered at the onset of respiratory exacerbation symptoms after enrolment, and are continued for one exacerbation only.

Locations(1)

Auckland, New Zealand

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