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NOT YET RECRUITING
NCT06409299
PHASE3

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

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Months - 72 Months

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-09-01

Completion Date

2027-08-31

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

DRUG

Azithromycin 40 MG/ML

Maintenance Antibiotic treatment

OTHER

Placebo

Placebo