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

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

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol
Creator	Grimwood, Keith Sloots, Theo Maclennan, Carolyn Sive, Alan Chang, Anne Mackay, Ian Mccallum, Gabrielle Morris, Peter White, Andrew
source	Medline; PMC
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, placebo-controlled 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, the intervention would lead to improved short term (and possibly long term) health benefits. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000326099
has issue date	2011-04-14(xsd:dateTime)
bibo:doi	10.1186/1745-6215-12-94
bibo:pmid	21492416
has license	cc-by
sha1sum (hex)	b34cc3d570e41a80c01088f73600357cf071a4da
schema:url	https://doi.org/10.1186/1745-6215-12-94
resource representing a document's title	Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol
has PubMed Central identifier	PMC3094234
has PubMed identifier	21492416
schema:publication	Trials
resource representing a document's body	covid:b34cc3d570e41a80c01088f73600357cf071a4da#body_text
is schema:about of	named entity 'AIRWAY INJURY' named entity 'GREATER' named entity 'FORM' named entity 'AZITHROMYCIN' named entity 'NON-' named entity 'MORBIDITY' named entity 'LATER IN LIFE' named entity 'PROPERTIES' named entity 'SEVERE' named entity 'LIKELY' named entity 'ACUTE' named entity 'TIME' named entity 'MORTALITY' named entity 'MORBIDITY' named entity 'INFANTS' named entity 'RATIONALE' named entity 'mortality' named entity 'AZITHROMYCIN' covid:arg/b34cc3d570e41a80c01088f73600357cf071a4da named entity 'LUNG GROWTH' named entity 'HAVE' named entity 'BRONCHIOLITIS' named entity 'HYPOTHESIS' named entity 'POST' named entity 'COMMON' named entity 'UPPER' named entity 'COMPARED' named entity 'LOWER AIRWAY' named entity 'CHRONIC' named entity 'GROWTH AND DEVELOPMENT' named entity 'TESTS' named entity 'ANTI-INFLAMMATORY' named entity 'CRITICAL' named entity 'INDIGENOUS' named entity 'RANDOMIZED PLACEBO-CONTROLLED TRIAL' named entity 'AUSTRALIAN' named entity 'BRONCHIOLITIS' named entity 'TO REDUCE' named entity 'PROTOCOL' named entity 'AIRWAYS' named entity 'YOUNG CHILDREN' named entity 'BACKGROUND' named entity 'LOWER' named entity 'AUSTRALIAN' named entity 'NATAL' named entity 'PULMONARY DISORDERS' named entity 'BACTERIAL' named entity 'INCREASES' named entity 'STUDY' named entity 'GLOBALLY' named entity 'INFANTS' named entity 'REPEATED' named entity 'CLINICAL OUTCOMES' named entity 'RESPIRATORY INFECTIONS' named entity 'THEIR' named entity 'INDIGENOUS' named entity 'CAUSE' named entity 'DENSITY' named entity 'OUR' named entity 'LIKELIHOOD' named entity 'EPISODES' named entity 'INFANCY' named entity 'PREVENTABLE' named entity 'MICROBIAL' named entity 'injury' named entity 'macrolides' named entity 'study design' named entity 'bronchiolitis' named entity 'respiratory illness' named entity 'Dutch' named entity 'immune modulation' named entity 'azithromycin' named entity 'bronchiolitis'

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