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

NCT06409299 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: p-2024-15966
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tracheomalacia; Bronchopulmonary Dysplasia (BPD); Vascular Ring; Cystic Lung Disease; Bronchiectasis; Chronic Atelectasis

Outcome Measures

Primary Outcomes (1)

• Incidence of exacerbations

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

  6 months

Secondary Outcomes (1)

• Severity of exacerbations

  6 months

Other Outcomes (2)

• Lung function measures

  1 year

• Quality of Life

  1 year

Study Arms (2)

Azithromycin Oral Suspension 40 mg/ml

ACTIVE COMPARATOR

Drug: Azithromycin 40 MG/ML

Placebo Oral suspension

PLACEBO COMPARATOR

Other: Placebo

Interventions

Azithromycin 40 MG/ML DRUG

Maintenance Antibiotic treatment

Azithromycin Oral Suspension 40 mg/ml

Placebo OTHER

Placebo

Placebo Oral suspension

Eligibility Criteria

• Age: 0 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

MeSH Terms

Conditions

Tracheomalacia; Bronchopulmonary Dysplasia; Vascular Ring; Cystic Disease Of Lung; Bronchiectasis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Tracheobronchomalacia; Cartilage Diseases; Musculoskeletal Diseases; Tracheal Diseases; Respiratory Tract Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study comprises a multicenter, parallel-group, double-blind, randomized placebo-controlled clinical trial (RCT) with a single intervention.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 14, 2024

Record last verified: 2024-05