Preventing recurrent acute lower respiratory infections in young First Nations and Timorese children using long-term, once-weekly azithromycin: a multicentre randomised controlled trial
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 First Nations and Timorese children hospitalised with an acute lower respiratory infection
Menzies School of Health Research
160 participants
Oct 20, 2020
Interventional
Conditions
Summary
Early and repeated acute lower respiratory infections (ALRI) in young children increase the risk for chronic lung diseases, such as bronchiectasis which is highly prevalent among First Nations populations. Our hypothesis is that First Nations and Timorese children receiving long-term azithromycin will have fewer medically-treated episode of ALRI within the first 12 months.
Eligibility
Inclusion Criteria5
- (1) First Nations (Australian Aboriginal and/or Torres Strait Islander; or NZ Maori and/or Pacific Islander; or Timorese)
- (2) Hospitalised with an ALRI (bronchiolitis or pneumonia) and resident of site hospitals catchment areas
- (2) Aged <2 years
- (3) Required oxygen or respiratory support at any point of current illness (including transfer and in the community) OR fluid support (NG or IV) OR have had recurrent ALRI-related admission within previous 3 months.
- In addition, New Zealand children are to be aged greater than or equal to 3 months, a condition required by the local human research ethics committee.
Exclusion Criteria5
- (1) Known chronic lung disease (e.g. cystic fibrosis, radiographic-confirmed bronchiectasis, chronic neonatal lung disease)
- (2) Receiving regular azithromycin (within the last 4 weeks)
- (3) Macrolide contraindicated (e.g. known liver dysfunction, hypersensitivity)
- (4) Primary carer lacks a mobile phone and/or is unable to attend follow-up clinical visits over the next 24-months
- (5) participation in another respiratory-related randomised controlled trial
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Interventions
All participants will be randomised during hospital admission for an acute lower respiratory infection. Participants will then receive active or placebo treatment for maximum 12 months, with a opt out option for children at 6 months. Active arm: 6-12 months of oral azithromycin (200mg/5ml) formulation, given weekly (30mg/kg per dose) Research staff or health centre staff will supervise weekly medication as above (oral suspension form) and complete medication diaries weekly.
Locations(3)
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ACTRN12619000456156