None listed
Conditions
Brief summary
The general aim of this project is to conduct a randomized, double-blind, placebo, placebo-controlled clinical trial of azithromycin to determine whether treatment from infancy is safe and will prevent the onset of bronchiectasis. One hundred and thirty infants will be recruited from CF clinics in Australia and New Zealand and treated from 3 months to three years of age. The primary outcome will be the proportion with radiologically-defined bronchiectasis at 3 years of age. Safety and mechanistic evaluations will also be undertaken.
Interventions
azithromycin liquid preparation given by oral administration 10 mg/kg three times a week from 3 months of age until 3 years of age
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Weeks to 6 Months
Healthy volunteers
No
Inclusion criteria
1. Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS); 2. Participants who, in the opinion of the Investigator, are able to comply with the protocol for its duration; 3. Written informed consent signed and dated by parent/legal guardian according to local regulations
Exclusion criteria
1. Born <30 weeks gestation; 2. Prolonged mechanical ventilation in the first 3 months of life; 3. Participation in another randomized controlled trial within the 3 months preceding inclusion in this study; 4. A significant medical disease or condition other than CF that is likely to interfere with the child’s ability to complete the entire protocol; 5. Previous major surgery except for meconium ileus; 6. Macrolide hypersensitivity
Outcome results
None listed