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

Inclusion Criteria3

Aged less than 18 years.
Bronchiectasis, as defined by HRCT scan within the last 5-years OR followed by a respiratory physician for treatment of bronchiectasis if diagnosed earlier.
or more respiratory exacerbations of bronchiectasis symptoms in the 18 months prior to study enrolment.

Exclusion Criteria1

Cystic Fibrosis (defined as measurement of sweat chloride >35mmol/L or by gene mutation). Liver dysfunction. Severe (hypoxic, dyspnoea or hospitalisation required) or recent exacerbation (in the 4 weeks prior to study enrolment). Known hypersensitivity to penicillins or macrolides. Taking regular maintenance antibiotics of the same class as the investigational antibiotics (macrolides and penicillins), or has taken macrolides or penicillins in the 3 weeks prior to study enrolment. Current or recent (within 4 months prior to study enrolment) identification of pseudomonas organism in the airways.

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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.