Prevention of Bronchiectasis in Infants With Cystic Fibrosis

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The general aim of this project is to conduct a randomized, double-blind, 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queensland Children's Medical Research Institute; The University of Queensland
• Collaborator: Telethon Kids Institute
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

1. Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS) for cystic fibrosis

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