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

Launched by RIGSHOSPITALET, DENMARK · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called azithromycin to see if it can help prevent lung infections in children who have certain lung conditions, such as tracheomalacia or bronchopulmonary dysplasia. These children often face repeated respiratory infections, which can lead to hospital visits and impact their overall health and quality of life. Although azithromycin is sometimes used to help with these issues, there hasn't been enough research to fully understand how effective it is for children with structural lung damage or malformations.

To be a part of this trial, children aged 0 to 72 months must have confirmed lung and airway problems and be at risk for infections that require antibiotics. They should also be receiving care from specialized pediatric lung doctors. Participants in this study will receive either azithromycin or a placebo (a non-active treatment) to see which one works better in preventing lung infections. This research aims to provide better treatment options for affected children and support their families in managing these challenging conditions.

Gender

ALL

Eligibility criteria

• 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.