CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

Prevention of Bronchiectasis in Infants With Cystic Fibrosis - Phase 3 - Recruiting

Study design (if review, criteria of inclusion for studies)

This study is currently recruiting participants. - Verified April 2016 - Allocation: Randomized|Endpoint Classification: Safety/Efficacy Study|Intervention Model: Parallel Assignment|Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)|Primary Purpose: Prevention

Participants

Child

Interventions

Drug: Azithromycin|Drug: Placebo control

Outcome measures

Proportion of children with radiologically-defined bronchiectasis|extent and severity of bronchiectasis|CF-related quality of life|time to first pulmonary exacerbation|proportion of participants experiencing a pulmonary exacerbation|body mass index|Proportion of participants growing Pseudomonas aeruginosa in bronchoalveolar lavage|age of acquisition of Pseudomonas aeruginosa|Emergence of macrolide-resistant Staphylococcus aureus, small colony variant Staphylococcal aureus and non-tuberculous mycobacterium|Volume of trapped gas at age 3 years

Keywords: Anti-Bacterial Agents; Azithromycin; Bronchiectasis; Child; Infant; pharmacological_intervention; placebo; prevention; Respiratory Tract Diseases; Macrolides; Anti-Inflammatory Agents; Anti-Inflammatory Agents - excl Steroids;