drugset / Trial / NCT06409299

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

NCT06409299

Phase 3 Not yet recruiting 150 enrolled Rigshospitalet, Denmark
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2024-09-01
Primary completion
2027-03-31
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azithromycin Small molecule 40 mg/ml Oral