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

Study acronym: TRALULALA-AZI
StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor Eligibility criteria shortened, about 2 words
    • Study title shortened, about 5 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06409299
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Conditions
(from sponsor)
Tracheomalacia, Bronchopulmonary Dysplasia (BPD), Vascular Ring, Cystic Lung Disease, Bronchiectasis, Chronic Atelectasis
Related terms Bronchiectasis, Bronchopulmonary Dysplasia, Cystic Disease Of Lung, Tracheomalacia, Vascular Ring
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov