ANZCTR - Registration

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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]

NIL

Universal Trial Number (UTN)

Trial acronym

ABIS2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bronchiolitis

Condition category

Condition code

Respiratory

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]

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]

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]

Assessed twice daily until conditions defined above are met

Secondary outcome [1]

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]

Assessed by review of medical chart until child is fully weaned off supplemental oxygen

Secondary outcome [2]

To determine the effect of treatment on readmissions into hospital within 6 months;

Timepoint [2]

Major secondary outcome is readmission for respiratory illness (within 6 months) according to a medical records review.

Secondary outcome [3]

To examine whether macrolide resistant respiratory pathogenes present in nasopharyngeal swabs influence clinical severity.

Timepoint [3]

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]

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]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2010

Actual

26/06/2010

Date of last participant enrolment

Anticipated

30/09/2013

Actual

26/09/2013

Date of last data collection

Anticipated

Actual

11/11/2013

Sample size

Target

219

Accrual to date

Final

219

Recruitment in Australia

Recruitment state(s)

NT,QLD

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Department of Health and Community Services operating in the Northern Territory

Ethics committee address [1]

Darwin Human Research Ethics Committee
PO BOX 41096
Casuarina
NT, 0811

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/03/2010

Ethics approval number [1]

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

Prof Anne Chang

Address

Menzies School of Health Research
PO Box 41096
Casuarina NT 0811

Country

Australia

Phone

+61 8 89228196

Fax

[email protected]

Contact person for public queries

Name

Ms Gabrielle McCallum

Address

Menzies School of Health Research
Po Box 41096
Casuarina NT, 0811

Country

Australia

Phone

+61 8 89228588

Fax

[email protected]

Contact person for scientific queries

Name

Prof Professor Anne Chang

Address

Menzies School of Health Research
Po Box 41096
Casuarina NT, 0811

Country

Australia

Phone

+61 8 89228196

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		McCallum GB, Morris PS, Grimwood K, Maclennan C, W... [More Details]	335394-(Uploaded-05-11-2019-09-13-57)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: Rationale and protocol.	2011	https://dx.doi.org/10.1186/1745-6215-12-94

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically