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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000456156

Acronym

PETAL Study

Enrollment

162

Registered

2019-03-20

Start date

2020-10-20

Completion date

2025-01-16

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

No minimum to 2 Years

Healthy volunteers

Inclusion criteria

(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 criteria

(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

Outcome results