ACTRN12619000456156
Recruiting
Phase 3
A multi-centre double-blind randomised controlled trial to determine if long-term once-weekly azithromycin (compared to placebo) reduces recurrent respiratory-related acute lower respiratory infections in young Indigenous children hospitalised with an acute lower respiratory infection
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute lower respiratory infection in children
- Sponsor
- Menzies School of Health Research
- Enrollment
- 160
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Indigenous (Australian Aboriginal and/or Torres Strait Islander; or New Zealander Maori
- •and/or Pacific Islander)
- •2\.Hospitalised with an ALRI (bronchiolitis or pneumonia)
- •3\.Aged \<2 years
- •4\. Resident of site hospitals catchment areas and follow\-up communities (NT only)
Exclusion Criteria
- •1\.Known chronic lung disease (e.g. cystic fibrosis, bronchiectasis)
- •2\.Already receiving regular azithromycin (within the last 4 weeks)
- •3\.Contraindication for macrolide use (e.g. liver dysfunction, hypersensitivity)
- •4\.Primary carer lacks a mobile phone for follow\-up; or
- •5\.Unable to attend follow up clinical visits over the next 24 months
Outcomes
Primary Outcomes
Not specified
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