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.

Phase 2

Completed

• Conditions: Bronchiolitis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12610000326099
• Lead Sponsor: Menzies School of Health Research, Darwin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-21
• Study Completion: 2013-11-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 219

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amongst hospitalised Indigenous children with bronchiolits does azithromycin (compared to placebo) improve clinical outcomes length of stay in hospital.<br><br>Length of stay in hospital for bronchiolitis <br>(defined as minimum of 16 hours off supplemented oxygen and feeding without complication). <br>Assessed twice daily until conditions defined above are met[Assessed twice daily until conditions defined above are met]