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Clinical Trials/ACTRN12610000383066
ACTRN12610000383066CompletedPhase 3

Among Indigenous children with bronchiectasis, does weekly azithromycin (compared to weekly placebo) reduce rates of exacerbation?

Menzies School of Health Research0 sites68 target enrollmentStarted: May 12, 2010Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
68
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
12 Months to 8 Years (—)
Sex
All

Inclusion Criteria

  • •Aboriginal, Pacific Islander or Maori children
  • •Aged between 12 months to 8 years (less than 9 years old)
  • •Current resident of study catchment community
  • •At least one episode of pulmonary exacerbation in the last 12 months
  • •No specific cause for bronchiectasis found despite appropriate investigation and hitorical review
  • •Diagnosed with definite bronchiectasis (High resolution CT confirmed) OR a clinical diagnosis of Chronic Supporative Lung Disease after appropriate investigations have been completed (including Full Blood Count, Immunoglobulins and chest Xray)

Exclusion Criteria

  • •Non Indigenous children. Incorrect age. Children who are on long term antibiotic use. Known cause of bronchiectasis such as cystic fibrosis, primary immnunodeficiency, Kartageners syndrome, primary ciliary dyskinesia, Marfans disease, severe burns, aspiration. Is currently undergoing treatment for cancer (having chemotherapy). Post transplant treatment (renal/cardiac and under immunosuppression treatment). Has diabetes. Has central or peripheral nervous system disorder. Has macrolide hypersensitivity. Non resident of study catchment area. Decision made by local doctor (or paediatrician) that long-term antibiotics or long-term placebo are not appropriate at this time.

Investigators

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