Preventing recurrent acute lower respiratory infections in young Indigenous children using long-term, once-weekly azithromycin: a multicentre randomised controlled trial

Phase 3

Recruiting

• Conditions: Acute lower respiratory infection in children; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12619000456156
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-20
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of medically-treated acute lower respiratory infections (ALRI). We will capture ALRI through the child's medical records (community or hospital) and at clinical visits.[ We aim to review these children at 12 months. Many children will reside in geographically isolated locations (in Australia), thus a range of 11-13 months is a reasonable time frame to capture ALRI data.]