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Prevention of Bronchiectasis in Infants With Cystic Fibrosis (COMBATCF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01270074
Recruitment Status : Active, not recruiting
First Posted : January 5, 2011
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
Telethon Kids Institute
Information provided by (Responsible Party):
Peter Sly, The University of Queensland

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 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 : May 2021


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


Locations
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Australia, New South Wales
Sydney Children's Hospital
Sydney, New South Wales, Australia
Westmead Children's Hospital
Sydney, New South Wales, Australia
Australia, Queensland
Mater Children's Hospital
Brisbane, Queensland, Australia
Royal Children's Hospital
Brisbane, Queensland, Australia
Australia, South Australia
Women's and Children's Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Monash Medical Centre
Melbourne, Victoria, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
New Zealand
Starship Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
The University of Queensland
Telethon Kids Institute
Investigators
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Study Chair: Peter D Sly, MMBS MD DSc The University of Queensland
Study Chair: Stephen M Stick, MBBChir PhD Telethon Kids Institute
Additional Information:
Publications:
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Responsible Party: Peter Sly, Protocol co-chair, The University of Queensland
ClinicalTrials.gov Identifier: NCT01270074    
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: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Keywords provided by Peter Sly, The University of Queensland:
double blind placebo controlled randomised clinical trial
azithromycin
infant
pediatric
cystic fibrosis
bronchiectasis
Additional relevant MeSH terms:
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Cystic Fibrosis
Bronchiectasis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchial Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents