Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000150347
Ethics application status
Approved
Date submitted
26/03/2008
Date registered
28/03/2008
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Date results information initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An intervention study for bronchiolitis in Darwin and Townsville - Comparing severity of disease and readmission of infants given azithromycin or placebo.
Scientific title
An intervention study for bronchiolitis in Darwin and Townsville - Comparing severity of disease and readmission of infants given azithromycin or placebo.
Secondary ID [1] 535 0
Nil
Universal Trial Number (UTN)
Trial acronym
ABIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 2963 0
Condition category
Condition code
Respiratory 3104 3104 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single, oral dose (30mg/kg) of azithromycin given to infants 18 months and less who are admitted to Royal Darwin Hospital with bronchiolitis.
Intervention code [1] 2710 0
Treatment: Drugs
Comparator / control treatment
placebo custom made to imitate the study drug in taste and smell.
Control group
Placebo

Outcomes
Primary outcome [1] 3994 0
Length of stay in hospital for bronchiolitis (defined as minimum of 16 hours off supplemented oxygen and feeding without complication).
Timepoint [1] 3994 0
Assessed twice daily until conditions defined above are met
Secondary outcome [1] 6719 0
Length of time on supplemental oxygen (medical charts reviewed every 12 hours until defined conditions met)
Timepoint [1] 6719 0
Assessed twice daily until conditions defined are met
Secondary outcome [2] 6720 0
Incidence of respiratory related readmissions, (medical charts reviewed at 6 months from date of hospital discharge)
Timepoint [2] 6720 0
Hospital review assessed at 6 months post discharge date of hospitalised bronchiolitis episode.

Eligibility
Key inclusion criteria
18 months of age and less Diagnosis of Bronchiolitis (defined as cough/coryza, wheezing +/- crackles, tachypnoea, retraction) requiring supplemented oxygen informed consent from parent/primary care giver
Minimum age
No limit
Maximum age
18 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to macrolide therapy,
chronic lung disease, currently on azithromycin therapy,
complex congenital heart disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A child who meets eligibilty criteria is enrolled and randomised to receive either azithromycin or placebo within strata of age (<6months and =/> 6 months) and ethnicity (Indigenous or non Indigenous).
Each child is allocated to the next randomly ordered treatment regime on a computer-generated list (permutated block design). The treatment allocation is concealed by sticker until enrollment. Medications are in identical bottles labelles A, B, C or D (two codes per treatment). A person independent of the study is responsible for allocating the treatment code and concealing the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence is generated from the website 'Randomization.com' (http://www.randomization.com) and concealed by a person not involved in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2008
Actual
18/07/2008
Date of last participant enrolment
Anticipated
2/12/2011
Actual
2/12/2011
Date of last data collection
Anticipated
Actual
2/12/2011
Sample size
Target
97
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
NT,QLD

Funding & Sponsors
Funding source category [1] 3224 0
Charities/Societies/Foundations
Name [1] 3224 0
Financial Markets Foundation for Children
Country [1] 3224 0
Australia
Funding source category [2] 237358 0
Charities/Societies/Foundations
Name [2] 237358 0
Channel 7 Children's Research Foundation of SA Inc
Country [2] 237358 0
Australia
Primary sponsor type
Hospital
Name
Royal Darwin Hospital
Address
Rocklands Drive, Tiwi
Darwin, NT
Country
Australia
Secondary sponsor category [1] 2887 0
Other
Name [1] 2887 0
Menzies School of Health Research
Address [1] 2887 0
John Mathews Buiding 58,
Royal Darwin Hospital
Rocklands Drive,
Darwin, NT
Country [1] 2887 0
Australia
Other collaborator category [1] 259 0
Hospital
Name [1] 259 0
Qld Paediatric Infectious Diseases Laboratory
Address [1] 259 0
Sir Albert Sakzewski Virus Research Centre
Royal Children's Hospital
Brisbane
Country [1] 259 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5210 0
Human Research Ethics Committee of NT Dept Health and Community Service and Menzies School of Health Research
Ethics committee address [1] 5210 0
Darwin
Ethics committee country [1] 5210 0
Australia
Date submitted for ethics approval [1] 5210 0
Approval date [1] 5210 0
03/12/2007
Ethics approval number [1] 5210 0
07/60

Summary
Brief summary
In a previous study on bronchiolitis in Aboriginal children we found that 67% were from remote communties and required retrievals. A recent study has also shown that almost 2.5% of Aboriginal children in Australia's Northern Territory will be hospitalised for bronchiolitis more than once before reaching the age of 18 months. Multiple hospitalised respiratory infections and the severity of these infections are risk factors for developing chronic lung diseases including bronchiectisis and asthma. It is planned that this study will provide an estimation of the effect of azithromycin on the severity of bronchiolitis in Aboriginal and non Aboriginal infants. Assessing redmission for respiratory illness within 6 months may provide some indication of the medium term benefit of a single dose of azithromycin, given to infants in the acute phase of viral bronchiolitis, in reducing the risk of further respiratory illness requiring hospitalisation.
Trial website
Trial related presentations / publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0074316
Public notes

Contacts
Principal investigator
Name 28467 0
Prof Anne Chang
Address 28467 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 28467 0
Australia
Phone 28467 0
+61889228196
Fax 28467 0
Email 28467 0
[email protected]
Contact person for public queries
Name 11624 0
Ms Gabrielle McCallum
Address 11624 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0810
Country 11624 0
Australia
Phone 11624 0
+61 8 89228588
Fax 11624 0
Email 11624 0
[email protected]
Contact person for scientific queries
Name 2552 0
Dr Dr Carolyn MacLennan
Address 2552 0
Royal Darwin Hospital,
Rocklands Drive,
Darwin NT 0811
Country 2552 0
Australia
Phone 2552 0
+61 8 8922 8888
Fax 2552 0
Email 2552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes McCallum GB, Morris PS, Chatfield MD, Maclennan C,... [More Details]
Basic resultsNo 82698-(Uploaded-05-11-2019-08-58-23)-Basic results summary.pdf
Plain language summaryNo In children hospitalised with moderate to severe b... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMobile phones support adherence and retention of indigenous participants in a randomised controlled trial: strategies and lessons learnt.2014https://dx.doi.org/10.1186/1471-2458-14-622
N.B. These documents automatically identified may not have been verified by the study sponsor.