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

Phase 3

Not yet recruiting

• Conditions: Bronchopulmonary Dysplasia (BPD); Tracheomalacia; Cystic Lung Disease; Bronchiectasis; Chronic Atelectasis; Vascular Ring
• Interventions: Drug: Azithromycin 40 MG/ML; Other: Placebo

• Registration Number: NCT06409299
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-10
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14
• Study Start: 2024-09-01
• Primary Completion: 2027-03-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. CT and bronchoscopy verified and structural lung damage or congenital lung and airway malformations
2. Outpatient affiliation with one of the three highly specialized pediatric pulmonology centers.
3. At risk of or already documented respiratory infections requiring antibiotics.
4. Age between 0-72 months at inclusion.

Exclusion Criteria

1. Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study.
2. Cystic fibrosis (CF) or primary ciliary dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded.
3. Impaired liver function: Children with an alanine transaminase (ALAT) twice or more the upper limits of normal will be excluded.
4. Impaired kidney function: Children with a serum creatinine higher than the upper limit of normal for age will be excluded.
5. Neurological or psychiatric disorders
6. Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded.
7. Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study.
8. Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin Oral Suspension 40 mg/ml	Azithromycin 40 MG/ML	-
Placebo Oral suspension	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of exacerbations	6 months	Number of exacerbations where systemic antibiotics is needed within the study period

Secondary Outcome Measures

Name	Time	Method
Severity of exacerbations	6 months	Duration of exacerbations, hospitalizations and durations of hospitalizations