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Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: a Randomized Controlled Trial on Azithromycin (AZI) for Airway Infection Prevention
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.
Age
0 - 6 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 1, 2024
Primary Completion Date
March 31, 2027
Completion Date
August 31, 2027
Last Updated
May 14, 2024
150
ESTIMATED participants
Azithromycin 40 MG/ML
DRUG
Placebo
OTHER
Lead Sponsor
Rigshospitalet, Denmark
Data Source & Attribution
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