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Prevention of Bronchiectasis in Infants With Cystic Fibrosis (COMBATCF)

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ClinicalTrials.gov Identifier: NCT01270074
Recruitment Status : Recruiting
First Posted : January 5, 2011
Last Update Posted : April 29, 2016
Sponsor:
Collaborator:
Telethon Kids Institute
Information provided by (Responsible Party):
Peter Sly, Queensland Children's Medical Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Bronchiectasis Drug: Azithromycin Drug: Placebo control Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.
Study Start Date : April 2012
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: azithromycin liquid preparation
azithromycin will be given at a dose of 10mg/kg given three times per week from three months of age to three years of age
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
Other Name: Zithromax

Active Comparator: inert liquid preparation
inert liquid preparation will be given three times per week from three months of age to 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




Primary Outcome Measures :
  1. Proportion of children with radiologically-defined bronchiectasis [ Time Frame: at three years of age ]
    bronchiectasis will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age


Secondary Outcome Measures :
  1. extent and severity of bronchiectasis [ Time Frame: at three years of age ]
    bronchiectasis will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age

  2. CF-related quality of life [ Time Frame: at three years of age ]
    Quality of life questionnaire to be measured at 3 years

  3. time to first pulmonary exacerbation [ Time Frame: over the first three years of life ]
    pulmonary exacerbation will be defined using a standardized instrument

  4. proportion of participants experiencing a pulmonary exacerbation [ Time Frame: over the first three years of life ]
    pulmonary exacerbation will be defined using a standardized instrument

  5. body mass index [ Time Frame: at three years of age ]
    body mass index will be calcualted from hieight and weight measurements taken at 3 years of age.

  6. Proportion of participants growing Pseudomonas aeruginosa in bronchoalveolar lavage [ Time Frame: over the first three years of life ]
    bronchoalveolar lavage will be performed at 3 months, 1 year and 3 years of age

  7. age of acquisition of Pseudomonas aeruginosa [ Time Frame: over the first three years of life ]
  8. Emergence of macrolide-resistant Staphylococcus aureus, small colony variant Staphylococcal aureus and non-tuberculous mycobacterium [ Time Frame: over the first three years of life ]
  9. Volume of trapped gas at age 3 years [ Time Frame: at 3 years ]
    air trapping will be determined from a low dose volumetric chest computed tomography scan performed at 3 years of age



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Ages Eligible for Study:   6 Weeks to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270074


Contacts
Contact: Stephen M Stick, MBBChir, PhD +61893408222 ext 8986 stephen.stick@health.wa.gov.au
Contact: Julie Varghese, PGDCTM +61736361283 julie.v@uq.edu.au

Locations
Australia, New South Wales
Sydney Children's Hospital Recruiting
Sydney, New South Wales, Australia
Principal Investigator: Adam Jaffe, FRACP         
Westmead Children's Hospital Recruiting
Sydney, New South Wales, Australia
Principal Investigator: Peter Cooper, FRACP         
Australia, Queensland
Mater Children's Hospital Recruiting
Brisbane, Queensland, Australia
Principal Investigator: Carolyn Dakin, FRACP         
Royal Children's Hospital Recruiting
Brisbane, Queensland, Australia
Principal Investigator: Claire Wainwright, FRACP         
Australia, South Australia
Women's and Children's Hospital Recruiting
Adelaide, South Australia, Australia
Principal Investigator: Andrew Tai, FRACP         
Australia, Victoria
Monash Medical Centre Recruiting
Melbourne, Victoria, Australia
Principal Investigator: David Armstrong, FRACP         
Royal Children's Hospital Recruiting
Melbourne, Victoria, Australia
Contact: Philip J Robinson, MD PhD Fracp       phil.robinson@rch.org.au   
Principal Investigator: Philip J Robinson, MD PhD FRACP         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Principal Investigator: Barry S Clements, MBBS         
New Zealand
Starship Hospital Recruiting
Auckland, New Zealand
Principal Investigator: Cass Byrnes, FRACP         
Christchurch Hospital Not yet recruiting
Christchurch, New Zealand
Principal Investigator: Philip Pattemore, FRACP         
Sponsors and Collaborators
Queensland Children's Medical Research Institute
Telethon Kids Institute
Investigators
Study Chair: Peter D Sly, MMBS MD DSc Queensland Children's Medical Research Institute
Study Chair: Stephen M Stick, MBBChir PhD Telethon Kids Institute

Additional Information:
Publications:
Responsible Party: Peter Sly, Protocol co-chair, Queensland Children's Medical Research Institute
ClinicalTrials.gov Identifier: NCT01270074     History of Changes
Other Study ID Numbers: AZI001
STICK10K0 ( Other Grant/Funding Number: Cystif Fibrosis Foundation Therapeutics, INc. )
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Peter Sly, Queensland Children's Medical Research Institute:
double blind placebo controlled randomised clinical trial
azithromycin
infant
pediatric
cystic fibrosis
bronchiectasis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Bronchiectasis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchial Diseases