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Prevention of Bronchiectasis in Infants With Cystic Fibrosis

NCT01270074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Azithromycin

azithromycin will be given as a liquid preparation at a dose of 10 mg/kg three times per week from three months of age until three years of age

DRUG

Placebo control

inert liquid preparation will be given three times per week from three months of age to three years of age

Sponsors & Collaborators

  • Telethon Kids Institute

    collaborator OTHER

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Peter D Sly, MMBS MD DSc · The University of Queensland

  • Stephen M Stick, MBBChir PhD · Telethon Kids Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2020-03-31
Completion
2021-03-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01270074 on ClinicalTrials.gov