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Azithromycin for Indigenous children with bronchiectasis study protocol for a multi centre randomized controlled trial

Valery, Patricia C., Morris, Peter S., Grimwood, Keith, Torzillo, Paul J., Byrnes, Catherine A., Masters, Ian B., Bauert, Paul, McCallum, Gabrielle B., Mobberly, Charmaine and Chang, Anne B. (2012). Azithromycin for Indigenous children with bronchiectasis study protocol for a multi centre randomized controlled trial. BMC Pediatrics,12(122):1-9.

Document type: Journal Article
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IRMA ID cmartelxPUB45
NHMRC Grant No. 389837 (clinical component)
545223 (microbiology component)
Title Azithromycin for Indigenous children with bronchiectasis study protocol for a multi centre randomized controlled trial
Author Valery, Patricia C.
Morris, Peter S.
Grimwood, Keith
Torzillo, Paul J.
Byrnes, Catherine A.
Masters, Ian B.
Bauert, Paul
McCallum, Gabrielle B.
Mobberly, Charmaine
Chang, Anne B.
Journal Name BMC Pediatrics
Publication Date 2012
Volume Number 12
Issue Number 122
ISSN 1471-2431   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-84864921065
Start Page 1
End Page 9
Total Pages 9
Place of Publication United Kingdom
Publisher BioMed Central Ltd.
HERDC Category C1 - Journal Article (DIISR)
Abstract Background
The prevalence of chronic suppurative lung disease (CSLD) and bronchiectasis unrelated to cystic fibrosis (CF) among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis.

Methods/design

We are conducting a multicentre, randomised, double-blind, placebo controlled clinical trial in Australia and New Zealand. Inclusion criteria are: Aboriginal, Torres Strait Islander, Maori or Pacific Island children aged 1 to 8 years, diagnosed with bronchiectasis (or probable bronchiectasis) with no underlying disease identified (such as CF or primary immunodeficiency), and having had at least one episode of pulmonary exacerbation in the last 12 months. After informed consent, children are randomised to receive either azithromycin (30 mg/kg once a week) or placebo (once a week) for 12–24 months from study entry. Primary outcomes are the rate of pulmonary exacerbations and time to pulmonary exacerbation determined by review of patient medical records. Secondary outcomes include length and severity of pulmonary exacerbation episodes, changes in growth, school loss, respiratory symptoms, forced expiratory volume in 1-second (FEV1; for children ≥6 years), and sputum characteristics. Safety endpoints include serious adverse events. Antibiotic resistance in respiratory bacterial pathogens colonising the nasopharynx is monitored. Data derived from medical records and clinical assessments every 3 to 4 months for up to 24 months from study entry are recorded on standardised forms.

Discussion

Should this trial demonstrate that azithromycin is efficacious in reducing the number of pulmonary exacerbations, it will provide a much-needed rationale for the use of long-term antibiotics in the medical management of bronchiectasis in Indigenous children.
Keywords Azithromycin
Bronchiectasis
Child
Chronic suppurative lung disease
Indigenous health
Placebo
Pulonary exacerbation
Randomised controlled trial
Antibiotic resistance
DOI http://dx.doi.org/10.1186/1471-2431-12-122   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)


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