Prevention of bronchiectasis in infants with cystic fibrosis
A Phase 3 multi-centre randomised placebo-controlled study of azithromycin in the primary prevention of radiologically-defined bronchiectasis in infants with cystic fibrosis
Telethon Kids Institute
130 participants
Jul 15, 2012
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS);
- Participants who, in the opinion of the Investigator, are able to comply with the protocol for its duration;
- Written informed consent signed and dated by parent/legal guardian according to local regulations
Exclusion Criteria6
- Born <30 weeks gestation;
- Prolonged mechanical ventilation in the first 3 months of life;
- Participation in another randomized controlled trial within the 3 months preceding inclusion in this study;
- A significant medical disease or condition other than CF that is likely to interfere with the child’s ability to complete the entire protocol;
- Previous major surgery except for meconium ileus;
- Macrolide hypersensitivity
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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
Locations(8)
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ACTRN12610001072000