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NCT Number: NCT06409299

Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: 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.

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Key information

Conditions

Tracheomalacia Aortic Arch Syndromes Aortic Diseases Bronchial Diseases Bronchiectasis Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia (BPD) Cardiovascular Abnormalities Cardiovascular Diseases Cartilage Diseases Chronic Atelectasis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cystic Disease Of Lung Cystic Lung Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Musculoskeletal Abnormalities Musculoskeletal Diseases Respiratory Tract Diseases Skin and Connective Tissue Diseases Tracheal Diseases Tracheobronchomalacia Vascular Diseases Vascular Malformations Vascular Ring Ventilator-Induced Lung Injury

Age range

0 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin 40 MG/ML

Drug

Maintenance Antibiotic treatment

Placebo

Other

Placebo

Primary outcomes

  1. Incidence of exacerbations

    Time frame: 6 months

    Number of exacerbations where systemic antibiotics is needed within the study period

Secondary outcomes

  1. Severity of exacerbations

    Time frame: 6 months

    Duration of exacerbations, hospitalizations and durations of hospitalizations

Other outcomes

  1. Lung function measures

    Time frame: 1 year

    Impulse oscillometry (IOS) measurement pre- and post drug administrations

  2. Quality of Life

    Time frame: 1 year

    Questionaire on a Likert scale 0-5. Using PedsQL(TM).

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: TRALULALA-AZI

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 10, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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