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Trial registered on ANZCTR
Registration number
ACTRN12610001072000
Ethics application status
Approved
Date submitted
2/12/2010
Date registered
6/12/2010
Date last updated
7/02/2020
Date data sharing statement initially provided
1/02/2019
Date results information initially provided
1/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Prevention of bronchiectasis in infants with cystic fibrosis
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Scientific 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
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Secondary ID [1]
253230
0
STICK10K0
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Universal Trial Number (UTN)
U1111-1118-3843
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Trial acronym
COMBAT CF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
bronchiectasis in cystic fibrosis
258763
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Condition category
Condition code
Respiratory
258909
258909
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
azithromycin liquid preparation given by oral administration 10 mg/kg three times a week from 3 months of age until 3 years of age
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Intervention code [1]
257698
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Prevention
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Comparator / control treatment
inert liquid preparation, identical in taste and colour, given by oral administration three times a week from 3 months of age until 3 years of age
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Proportion of children with radiologically-defined bronchiectasis
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Assessment method [1]
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Timepoint [1]
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three years of age
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Secondary outcome [1]
268533
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extent and severity of bronchiectasis
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Assessment method [1]
268533
0
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Timepoint [1]
268533
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three years of age
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Secondary outcome [2]
268534
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CF-related quality of life
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Assessment method [2]
268534
0
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Timepoint [2]
268534
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three years of age
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Secondary outcome [3]
268535
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time to first pulmonary exacerbation
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Assessment method [3]
268535
0
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Timepoint [3]
268535
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3 years of age
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Secondary outcome [4]
268536
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proportion of participants experiencing a pulmonary exacerbation
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Assessment method [4]
268536
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Timepoint [4]
268536
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3 years of age
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Secondary outcome [5]
268537
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number of courses of inhaled or oral antibiotics
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Assessment method [5]
268537
0
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Timepoint [5]
268537
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3 years of age
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Secondary outcome [6]
268538
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number of days of inhaled antibiotics
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Assessment method [6]
268538
0
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Timepoint [6]
268538
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3 years of age
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Secondary outcome [7]
268539
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incidence of hospitalizations/Accident & Emergency visitsfor acute respiratory exacerbations
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Assessment method [7]
268539
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Timepoint [7]
268539
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3 years of age
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Secondary outcome [8]
268540
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number of days of hospitalization and number of days of intravenous antibiotics for acute respiratory exacerbations
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Assessment method [8]
268540
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Timepoint [8]
268540
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3 years of age
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Secondary outcome [9]
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volume of trapped gas at age 3 years assessed using a low dose volumetric computed tomography scan
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Assessment method [9]
279410
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Timepoint [9]
279410
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3 years of age
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Secondary outcome [10]
279411
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Body mass index
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Assessment method [10]
279411
0
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Timepoint [10]
279411
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3 years of age
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Eligibility
Key inclusion criteria
1. Children of either sex with a diagnosis of CF following detection via New Born Screening (NBS);
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
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Minimum age
6
Weeks
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Maximum age
6
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are enrolled following confirmation of cystic fibrosis via new born screening. Randomisation by IWRS.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization stratified by study site
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/01/2012
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Actual
15/07/2012
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Date of last participant enrolment
Anticipated
31/05/2017
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Actual
3/05/2017
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Date of last data collection
Anticipated
31/05/2021
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Actual
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Sample size
Target
130
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Accrual to date
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Final
130
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
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Recruitment hospital [1]
7759
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Princess Margaret Hospital - Subiaco
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Recruitment hospital [2]
7760
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The Royal Childrens Hospital - Parkville
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Recruitment hospital [3]
7761
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Lady Cilento Children's Hospital - South Brisbane
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Recruitment hospital [4]
7762
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [5]
7763
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Sydney Children's Hospital - Randwick
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Recruitment hospital [6]
7764
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Womens and Childrens Hospital - North Adelaide
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Recruitment postcode(s) [1]
3494
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6008
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Recruitment postcode(s) [2]
3495
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4101
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Recruitment postcode(s) [3]
3496
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4029
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Recruitment postcode(s) [4]
3497
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2145
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Recruitment postcode(s) [5]
3498
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2031
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Recruitment postcode(s) [6]
3500
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3052
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Recruitment postcode(s) [7]
3501
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3168
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Recruitment postcode(s) [8]
3502
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5006
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Recruitment postcode(s) [9]
15693
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6008 - Subiaco
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Recruitment postcode(s) [10]
15694
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3052 - Parkville
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Recruitment postcode(s) [11]
15695
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4101 - South Brisbane
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Recruitment postcode(s) [12]
15696
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2145 - Westmead
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Recruitment postcode(s) [13]
15697
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2031 - Randwick
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Recruitment postcode(s) [14]
15698
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5006 - North Adelaide
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Recruitment outside Australia
Country [1]
3072
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New Zealand
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State/province [1]
3072
0
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Country [2]
5309
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New Zealand
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State/province [2]
5309
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Christchurch
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Funding & Sponsors
Funding source category [1]
258170
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Charities/Societies/Foundations
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Name [1]
258170
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Cystic Fibrosis Foundation Therapeutics Inc
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Address [1]
258170
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Grants and Contracts office
6931 Arlington Rd
Bethesda Maryland 20814
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Country [1]
258170
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United States of America
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Primary sponsor type
Other
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Name
Telethon Kids Institute
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Address
100 Roberts Rd
Subiaco WA 6008
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Country
Australia
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Secondary sponsor category [1]
257344
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Other
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Name [1]
257344
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Queensland Children's Medical Research Institute
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Address [1]
257344
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Level 4, Foundation Building
Royal Children's Hospital
Herston Rd, Herston Qld 4029
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Country [1]
257344
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260158
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Princess Margaret Hospital for Children Human Ethics Committee
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Ethics committee address [1]
260158
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Roberts Road
Subiaco WA 6008
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Ethics committee country [1]
260158
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Australia
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Date submitted for ethics approval [1]
260158
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Approval date [1]
260158
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15/04/2010
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Ethics approval number [1]
260158
0
1795/EP
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31984
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Prof Stephen Stick
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Address
31984
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Department of Respiratory Medicine
Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008
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Country
31984
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Australia
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Phone
31984
0
+61 8 9340 8830
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Fax
31984
0
+61 8 9340 8181
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Email
31984
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[email protected]
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Contact person for public queries
Name
15231
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Ms Nat Eiffler
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Address
15231
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Telethon Kids Institute
100 Roberts Rd
SUBIACO WA 6008
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Country
15231
0
Australia
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Phone
15231
0
+61 8 94897814
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Fax
15231
0
+61 7 3636 5578
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Email
15231
0
[email protected]
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Contact person for scientific queries
Name
6159
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Prof Professor Stephen Stick
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Address
6159
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Department of Respiratory Medicine
Princess Margaret Hospital for Children
Ropberts Rd
Subiaco WA 6008
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Country
6159
0
Australia
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Phone
6159
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+61893408830
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Fax
6159
0
+61893408181
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Email
6159
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Early intervention studies in infants and preschool children with cystic fibrosis: are we ready?
2013
https://doi.org/10.1183/09031936.00108212
N.B. These documents automatically identified may not have been verified by the study sponsor.
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