NCT06409299

Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention

Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: a Randomized Controlled Trial on Azithromycin (AZI) for Airway Infection Prevention

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 0 Months – 72 Months
• Healthy volunteers: Not accepted

Summary

Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed. The link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. Although antibiotics can alleviate symptoms, relapse is common. Experts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population. To address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. This research aims to inform clinical practice and improve the health of affected children and their families.

Conditions

• Tracheomalacia
• Bronchopulmonary Dysplasia (BPD)
• Vascular Ring
• Cystic Lung Disease
• Bronchiectasis
• Chronic Atelectasis

Interventions

Type	Name	Description
DRUG	Azithromycin 40 MG/ML	Maintenance Antibiotic treatment
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-03-31
• Completion: 2027-08-31
• First posted: 2024-05-10
• Last updated: 2024-05-14