AZITHROMYCIN for Chronic atelectasis|Cystic lung malformations|Bronchiectasis|Bronchopulmonary dysplasia|Tracheomalacia|Lobar hyperinflation syndrome|Post-vascular ring with central airway compression

Inclusion criteria

• {"criterion_text":"- Radiologically or/and bronchoscopy verified structural lung damage or congenital lung and airway malformations\n- Outpatient affiliation with one of the three specialized pediatric pulmonology centers in Denmark.\n- At risk of or already documented respiratory infections requiring antibiotics.\n- Age between 0-72 months.\n- Parents provide written informed consent for their child to participate in the trial, according to local regulations."}

Exclusion criteria

• {"criterion_text":"- Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study\n- Current treatment with medication known to interact with AZI: ciclosporin, coumarin-like oral anticoagulants (e.g. warfarin), digoxin, ergotamine derivatives (e.g. methylergometrine), nelfinavir, rifabutin and active substances known to prolong QT interval such as amiodarone and other class ΙA and class ΙΙΙ antiarrhythmics, cisapride, terfenadin, moxifloxacin and levofloxacin, antipsychotic agents such as pimozide and antidepressants such as citalopram\n- Cystic fibrosis (CF) or Primary Ciliary Dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded\n- Children already receiving AZI 3 times a week to prevent infections\n- Impaired liver function: Children with an alanine transaminase (ALAT) > twice the upper limits of normal will be excluded\n- Impaired kidney function: Children with GFR < 50 ml/min will be excluded\n- Neurological or psychiatric disorders will be excluded\n- Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded\n- Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study\n- Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study"}

Primary endpoints

• {"endpoint_text":"- Difference in the number of respiratory exacerbations between the treatment groups in the intervention period in the intervention period","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Difference in duration of exacerbations between the treatment groups in the intervention period\n- Difference in number of hospital admissions between the treatment groups in the intervention period\n- Difference in duration of hospital admissions between the treatment groups in the intervention period","definition_or_measurement_approach":""}

Methods

• Recruitment through outpatient affiliation with one of the three specialized pediatric pulmonology centers in Denmark (Rigshospitalet; Aarhus Universitet/Skejby; Odense University Hospital).

Denmark

Earliest CTIS Part Ii Submission Date

05-11-2025

Latest Decision Or Authorization Date

20-03-2026

Processing Time Days

135

Number Of Sites

3

Number Of Participants

150

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsor duty code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Region Hovedstadens Apotek Herlev Hospital","duties_or_roles":"sponsor duty code 14","organisation_type":"Pharmaceutical company"}