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

Bronchiectasis Clinical Trial

— TRALULALA-AZI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409299
• Other study ID #: p-2024-15966
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: May 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 72 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchopulmonary Dysplasia
• Bronchopulmonary Dysplasia (BPD)
• Lung Diseases
• Pulmonary Atelectasis
• Tracheomalacia
• Vascular Ring

Intervention

Drug:
• Azithromycin 40 MG/ML
Maintenance Antibiotic treatment

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung function measures	Impulse oscillometry (IOS) measurement pre- and post drug administrations	1 year
Other	Quality of Life	Questionaire on a Likert scale 0-5. Using PedsQL(TM).	1 year
Primary	Incidence of exacerbations	Number of exacerbations where systemic antibiotics is needed within the study period	6 months
Secondary	Severity of exacerbations	Duration of exacerbations, hospitalizations and durations of hospitalizations	6 months