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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 September 2021 |
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Main ID: |
NCT01270074 |
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Date of registration:
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23/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prevention of Bronchiectasis in Infants With Cystic Fibrosis
COMBATCF |
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Scientific title:
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A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis. |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01270074 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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New Zealand
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Contacts
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Name:
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Stephen M Stick, MBBChir PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Telethon Kids Institute |
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Name:
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Peter D Sly, MMBS MD DSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Queensland |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Weeks
Age maximum:
6 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Bronchiectasis
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Intervention(s)
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Drug: Placebo control
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Drug: Azithromycin
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Primary Outcome(s)
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Proportion of children with radiologically-defined bronchiectasis
[Time Frame: at three years of age]
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The proportion of lung tissue affected by disease
[Time Frame: at three years of age]
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Secondary Outcome(s)
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extent and severity of bronchiectasis
[Time Frame: at three years of age]
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proportion of participants experiencing a pulmonary exacerbation
[Time Frame: over the first three years of life]
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body mass index
[Time Frame: at three years of age]
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Proportion of participants growing Pseudomonas aeruginosa in bronchoalveolar lavage
[Time Frame: over the first three years of life]
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Volume of trapped gas at age 3 years
[Time Frame: at 3 years]
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CF-related quality of life
[Time Frame: at three years of age]
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Emergence of macrolide-resistant Staphylococcus aureus, small colony variant Staphylococcal aureus and non-tuberculous mycobacterium
[Time Frame: over the first three years of life]
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time to first pulmonary exacerbation
[Time Frame: over the first three years of life]
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age of acquisition of Pseudomonas aeruginosa
[Time Frame: over the first three years of life]
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Secondary ID(s)
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AZI001
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STICK10K0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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