CompletedPhase 4ACTRN12612000010897

Antibiotics for treatment of bronchiectasis exacerbations in children - The Bronchiectasis Exacerbation Study (Study 2).

A randomised, double blind trial of Azithromycin versus Amoxycillin-Clavulate to treat mild to moderate respiratory exacerbations in children with non-Cystic Fibrosis bronchiectasis, Study Two.

Sponsor

Qld Children's Medical Research Institute

Enrollment

170 participants

Start Date

Oct 1, 2012

Study Type

Interventional

Conditions

Bronchiectasis

Summary

Our national study aims to improve the management 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 respiratory exacerbations with one of two different oral antibiotics is more effective at resolving the exacerbation. 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 last 18 months prior to study enrolment.

Exclusion Criteria1

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

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Interventions

Arm 1: Daily oral Azithromycin 5mg/kg for 21 days Arm 2: Twice daily oral Amoxycillin-Clavulanic Acid 22.5mg/kg for 21 days These treatments are administered at the onset of respiratory exacerbati

Arm 1: Daily oral Azithromycin 5mg/kg for 21 days Arm 2: Twice daily oral Amoxycillin-Clavulanic Acid 22.5mg/kg for 21 days These treatments are administered at the onset of respiratory exacerbation after enrolment, and are administered only for one respiratory exacerbation.