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Clinical Trials/ACTRN12612000010897
ACTRN12612000010897
Completed
Phase 4

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.

Qld Children's Medical Research Institute0 sites170 target enrollmentJanuary 4, 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Bronchiectasis
Sponsor
Qld Children's Medical Research Institute
Enrollment
170
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 4, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Qld Children's Medical Research Institute

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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