ActivePhase 3ACTRN12610001072000

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


Sponsor

Telethon Kids Institute

Enrollment

130 participants

Start Date

Jul 15, 2012

Study Type

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

Sex: Both males and femalesMin Age: 6 WeekssMax Age: 6 Monthss

Plain Language Summary

Simplified for easier understanding

This study tests whether an antibiotic treatment can prevent lung damage (bronchiectasis) in infants newly diagnosed with cystic fibrosis. Babies aged 6 weeks to 6 months who were detected through newborn screening are eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Princess Margaret Hospital - Subiaco

NSW,QLD,SA,WA,VIC, Australia

The Royal Childrens Hospital - Parkville

NSW,QLD,SA,WA,VIC, Australia

Lady Cilento Children's Hospital - South Brisbane

NSW,QLD,SA,WA,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,QLD,SA,WA,VIC, Australia

Sydney Children's Hospital - Randwick

NSW,QLD,SA,WA,VIC, Australia

Womens and Childrens Hospital - North Adelaide

NSW,QLD,SA,WA,VIC, Australia

New Zealand

Christchurch, New Zealand

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ACTRN12610001072000