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

Phase 3

Recruiting

• Conditions: Chronic wet cough; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12623000098639
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-27
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 274

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children with recurrent protracted bacterial bronchitis (PBB) >3 episodes PBB/year or bronchiectasis. These will be collected by participant reports and medical records.[ Within 12 months for PBB recurrence <br>Within 24 months of enrolment for bronchiectasis]