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Not yet recruiting NCT06409299

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

Phase III Interventional Tracheomalacia Bronchopulmonary Dysplasia (BPD) Vascular Ring Cystic Lung Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Azithromycin 40 MG/ML, Placebo.
Who it may be relevant to
Registry conditions: Tracheomalacia, Bronchopulmonary Dysplasia (BPD), Vascular Ring, Cystic Lung Disease. Basic parameters: 0 months — 72 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Azithromycin 40 MG/ML
    Maintenance Antibiotic treatment
  • Other Placebo
    Placebo

Primary outcome measures

  • Incidence of exacerbations [Time frame: 6 months]
Secondary outcome measures (1)
  • Severity of exacerbations [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06409299 · p-2024-15966

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗