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

Phase 4

Completed

• Conditions: Bronchiectasis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12612000010897
• Lead Sponsor: Qld Children's Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

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.
2 or more respiratory exacerbations of bronchiectasis symptoms in the last 18 months prior to study enrolment.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of children with resolution of the respiratory exacerbation (defined by return to baseline state of signs and symptoms). Baseline stat is determined by physician assessment of cough, sputum color and chest sounds at time of enrolment into study protocol.[21 days after initiation of treatment (Azithromycin OR Amoxycillin-Clavulanic acid).]