Charles Darwin University

CDU eSpace
Institutional Repository

 
CDU Staff and Student only
 

Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol

Chang, Anne B., Grimwood, Keith, White, Andrew V., Maclennan, Carolyn, Sloots, Theo P., Sive, Alan, McCallum, Gabrielle B., Mackay, Ian M. and Morris, Peter S. (2011). Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol. Trials,12(1):94-101.

Document type: Journal Article
Attached Files (Some files may be inaccessible until you login with your CDU eSpace credentials)
Name Description MIMEType Size Downloads
Read with bookreader Download this reading  Chang_24375.pdf Published version application/pdf 318.29KB 63
Reading the attached file works best in Firefox, Chrome and IE 9 or later.

IRMA ID jsingletonxPUB16
Title Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol
Author Chang, Anne B.
Grimwood, Keith
White, Andrew V.
Maclennan, Carolyn
Sloots, Theo P.
Sive, Alan
McCallum, Gabrielle B.
Mackay, Ian M.
Morris, Peter S.
Journal Name Trials
Publication Date 2011
Volume Number 12
Issue Number 1
ISSN 1745-6215   (check CDU catalogue  open catalogue search in new window)
Start Page 94
End Page 101
Total Pages 8
Place of Publication United Kingdom
Publisher BioMed Central Ltd.
Abstract Background: Acute lower respiratory infections are the commonest cause of morbidity and potentially preventable mortality in Indigenous infants. Infancy is also a critical time for post-natal lung growth and development. Severe or repeated lower airway injury in very young children likely increases the likelihood of chronic pulmonary disorders later in life. Globally, bronchiolitis is the most common form of acute lower respiratory infections during infancy. Compared with non-Indigenous Australian infants, Indigenous infants have greater bacterial density in their upper airways and more severe bronchiolitis episodes. Our study tests the hypothesis that the anti microbial and anti-inflammatory properties of azithromycin, improve the clinical outcomes of Indigenous Australian infants hospitalised with bronchiolitis.

Methods: We are conducting a dual centre, randomised, double-blind, placebo-controlled, parallel group trial in northern Australia. Indigenous infants (aged ≤ 24-months, expected number = 200) admitted to one of two regional hospitals (Darwin, Northern Territory and Townsville, Queensland) with a clinical diagnosis of bronchiolitis and fulfilling inclusion criteria are randomised (allocation concealed) to either azithromycin (30 mg/kg/dose) or placebo administered once weekly for three doses. Clinical data are recorded twice daily and nasopharyngeal swab are collected at enrolment and at the time of discharge from hospital. Primary outcomes are ‘length of oxygen requirement’ and ‘duration of stay,’ the latter based upon being judged as ‘ready for respiratory discharge’. The main secondary outcome is readmission for a respiratory illness within 6-months of leaving hospital. Descriptive virological and bacteriological (including development of antibiotic resistance) data from nasopharyngeal samples will also be reported.

Discussion: Two published studies, both involving different patient populations and settings, as well as different macrolide antibiotics and treatment duration, have produced conflicting results. Our randomised, placebocontrolled trial of azithromycin in Indigenous infants hospitalised with bronchiolitis is designed to determine whether it can reduce short-term (and potentially long-term) morbidity from respiratory illness in Australian Indigenous infants who are at high risk of developing chronic respiratory illness. If azithromycin is efficacious in reducing the morbidly of Indigenous infants hospitalised with bronchiolitis
Keywords azithromycin
bronchiolitis
Indigenous infants
DOI http://dx.doi.org/doi:10.1186/1745-6215-12-94   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)


© copyright

Every reasonable effort has been made to ensure that permission has been obtained for items included in CDU eSpace. If you believe that your rights have been infringed by this repository, please contact digitisation@cdu.edu.au.

 
Versions
Version Filter Type
Access Statistics: 41 Abstract Views, 71 File Downloads  -  Detailed Statistics
Created: Tue, 23 Oct 2012, 09:43:59 CST by Iwona Rohoza