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.

Amongst hospitalised Indigenous infants with bronchiolitis, does azithromycin (compared to placebo) improve clinical outcomes (length of stay in hospital and duration of oxygen supplementation)?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000326099

Acronym

ABIS2

Enrollment

219

Registered

2010-04-21

Start date

2010-06-26

Completion date

2013-09-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 24 Months

Healthy volunteers

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

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

Outcome results