Long-term treatment with azithromycin to prevent bronchiectasis and recurrent cough (LEAP-Cough)

The effectiveness of long-term treatment with azithromycin to prevent bronchiectasis and recurrent cough (LEAP-Cough) and developing individualised approaches for children with chronic wet cough

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000098639

Acronym

LEAP-Cough

Enrollment

236

Registered

2023-01-27

Start date

2023-07-03

Completion date

2027-12-31

Last updated

2025-09-08

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

Conditions

None listed

Brief summary

Chronic wet cough (CWC) is among the commonest symptoms of chronic lung disease. In children, it is associated with bronchiectasis (BE), recurrent doctor visits and impaired quality-of-life (QoL). Early diagnosis/treatment leads to decreased cost and, improved QoL and clinical outcomes. Yet, there is currently there are no published data on treatable traits in children with child CWC or intervention that prevents BE. Our primary question is: In children with CWC and with ‘high-risk traits’ (recurrent antibiotics for CWC, airway H. influenzae infection or cough duration >6-mo), does 9-mo of azithromycin (vs controls) reduce the risk of future recurrent protracted bacterial bronchitis (recPBB) and BE? Our secondary aims are to determine if 9-mo of regular azithromycin (vs. controls) improve other clinical outcomes (lung function, time-to-next exacerbation, recurrence rate, and time off work/school) and its cost-effectiveness, in children with CWC and with ‘high-risk traits’.

Interventions

Azithromycin: Oral 10mg/kg/dose (max 500 mg/dose), 3x weekly for 9 months or 30mg/kg/dose weekly. Supplied as powder for suspension or tablet. The type (powder or tablet) and frequency (x3/week or weekly) will be determined based on the child's age, preference and setting. Adherence will be monitored by diary monitoring and collection of medication from the pharmacy.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

2 Months to 19 Years

Healthy volunteers

Inclusion criteria

1. Children aged 2 months-19 years 2. Suspected of having PBB i.e current or past history of chronic wet cough 3. Plan to remain in contact with one of the study sites for 24 months 4. Have one or more ‘high-risk traits’ • Cough duration >6-months • Recurrent antibiotics use [>3 episodes to treat chronic wet cough in preceding 12-mo] or • Airway Haemophilus influenzae infection.

Exclusion criteria

1. Presence of chronic cough pointers suggesting other causes of CWC- based on treating clinicians’ evaluation. (eg. bronchiectasis); 2. Known chronic lung disease eg. CT confirmed bronchiectasis (asthma not excluded as many children with PBB are misdiagnosed) or 3. Previously enrolled. 4. Contraindication to azithromycin (known liver dysfunction, known hypersensitivity to Azithromycin) or 5. Enrolled in another current RCT.

Outcome results