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Trial registered on ANZCTR


Registration number
ACTRN12610000326099
Ethics application status
Approved
Date submitted
19/04/2010
Date registered
21/04/2010
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Date results information initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Azithromycin bronchiolitis Intervention Study 2: An multicenter intervention study for bronchiolitis in Darwin Townsville and Auckalnd - Comparing severity of disease and readmission of infants given azithromycin or placebo.
Scientific title
Amongst hospitalised Indigenous infants with bronchiolitis, does azithromycin (compared to placebo) improve clinical outcomes (length of stay in hospital and duration of oxygen supplementation)?
Secondary ID [1] 251634 0
NIL
Universal Trial Number (UTN)
Trial acronym
ABIS2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 257214 0
Condition category
Condition code
Respiratory 257355 257355 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single weekly oral doses for three weeks (30mg/kg) of azithromycin given to infants 24 months and less who are admitted with bronchiolitis over three weeks.
Intervention code [1] 256335 0
Treatment: Drugs
Comparator / control treatment
Control treatment: Placebo is custom made to imitate the study drug in taste and smell but does not contain the active ingredient.

A single weekly oral doses for three weeks (30mg/kg) of Placebo given to infants 24 months and less who are admitted with bronchiolitis.
Control group
Placebo

Outcomes
Primary outcome [1] 258255 0
Amongst hospitalised Indigenous children with bronchiolits does azithromycin (compared to placebo) improve clinical outcomes length of stay in hospital.

Length of stay in hospital for bronchiolitis
(defined as minimum of 16 hours off supplemented oxygen and feeding without complication).
Assessed twice daily until conditions defined above are met
Timepoint [1] 258255 0
Assessed twice daily until conditions defined above are met
Secondary outcome [1] 263912 0
Amongst hospitalised Indigenous children with bronchiolits does azithromycin (compared to placebo) improve clinical outcomes by reducing the number of hours of supplemented oxygen requirement.

Assessed by review of medical chart until child is fully weaned off supplemental oxygen
Timepoint [1] 263912 0
Assessed by review of medical chart until child is fully weaned off supplemental oxygen
Secondary outcome [2] 263941 0
To determine the effect of treatment on readmissions into hospital within 6 months;
Timepoint [2] 263941 0
Major secondary outcome is readmission for respiratory illness (within 6 months) according to a medical records review.
Secondary outcome [3] 304931 0
To examine whether macrolide resistant respiratory pathogenes present in nasopharyngeal swabs influence clinical severity.

Timepoint [3] 304931 0
Nasopharyngel swabs will be taken from participants at enrolment and then 48 hours later (or as close to discharge as possible). The nasopharngeal swabs will be batched and processed in our laboratory throughout the trial at convenient times for the laboratory staff, using established techniques. Laboratory staff remain blinded to participants treatment groups until after unblinding once analysis complete.

Assessed at time of laboratory processing/testing
Secondary outcome [4] 304932 0
Nasopharyngel swabs will be taken from participants at enrolment and then 48 hours later (or as close to discharge as possible). To assess the short-term impact of azithromycin on macrolide resistance patterns of respiratory pathogens in the nasopharynx.
Timepoint [4] 304932 0
Nasopharyngel swabs will be taken from participants at enrolment and then 48 hours later (or as close to discharge as possible). Nasopharyngel swabs will be batched and processed in our laboratory throughout the trial at convenient times for the laboratory staff, using established techniques. Laboratory staff remain blinded to participants treatment groups until after unblinding once analysis complete.


Assessed at time of laboratory processing/testing
Secondary outcome [5] 304933 0
To describe the point prevalence and diversity of respiratory viruses,Mycoplasma pneumoniae and Chlamydia species (C. pneumoniae, C. trachomatis, Simkania negevensis) using sensitive molecular diagnostic techniques.
Timepoint [5] 304933 0
Nasopharyngel swabs will be taken from participants at enrolment and then 48 hours later (or as close to discharge as possible). Nasopharyngel swabs will be batched and sent to the Queenslan'ds Paediatric Infectious Diseases lab throughout the trial. Batches will be sent at convenient times for this laboratory. One final batch will be sent for processing once the final child has been recruited. Laboratory staff remain blinded to participants treatment groups until after unblinding once analysis complete.

Assessed at time of laboratory processing/testing.

Eligibility
Key inclusion criteria
1.Informed consent 2.Australian Aboriginal, Torres Strait Islander, Maori or Pacific Islander 3.Aged under 24 months of age 4.Admitted to hospital with diagnosis of bronchiolitits
Minimum age
No limit
Maximum age
24 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Has chronic lung disease or bronchiectasis
2.Has a current diagnosis of gastroenteritis
3.Has been administered azithromycin in the past 7 days

4.Has liver function impairment
5.Has cyanotic congenital heart disease

6.Has been receiving oxygen for longer than 24 hours in admitting hospital

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD
Recruitment outside Australia
Country [1] 2594 0
New Zealand
State/province [1] 2594 0
Auckland

Funding & Sponsors
Funding source category [1] 256839 0
Government body
Name [1] 256839 0
NHMRC
Address [1] 256839 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country [1] 256839 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research, Darwin
Address
Po box 41096
Casuarina, NT, 0811
Country
Australia
Secondary sponsor category [1] 256115 0
None
Name [1] 256115 0
Address [1] 256115 0
Country [1] 256115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258856 0
Department of Health and Community Services operating in the Northern Territory
Ethics committee address [1] 258856 0
Darwin Human Research Ethics Committee
PO BOX 41096
Casuarina
NT, 0811
Ethics committee country [1] 258856 0
Australia
Date submitted for ethics approval [1] 258856 0
Approval date [1] 258856 0
30/03/2010
Ethics approval number [1] 258856 0
2010-1324

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 three doses 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
Public notes

Contacts
Principal investigator
Name 31073 0
Prof Anne Chang
Address 31073 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 31073 0
Australia
Phone 31073 0
+61 8 89228196
Fax 31073 0
Email 31073 0
anne.chang@menzies.edu.au
Contact person for public queries
Name 14320 0
Ms Gabrielle McCallum
Address 14320 0
Menzies School of Health Research
Po Box 41096
Casuarina NT, 0811
Country 14320 0
Australia
Phone 14320 0
+61 8 89228588
Fax 14320 0
Email 14320 0
gabrielle.mccallum@menzies.edu.au
Contact person for scientific queries
Name 5248 0
Prof Professor Anne Chang
Address 5248 0
Menzies School of Health Research
Po Box 41096
Casuarina NT, 0811
Country 5248 0
Australia
Phone 5248 0
+61 8 89228196
Fax 5248 0
Email 5248 0
anne.chang@menzies.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5645 0
McCallum GB, Morris PS, Grimwood K, Maclennan C, White AV, Chatfield MD, et al. Three-weekly doses of azithromycin for indigenous infants hospitalized with bronchiolitis: a multicentre, randomized, placebo-controlled trial. Frontiers in pediatrics. 2015;3:32.
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary