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, I. Brent, Bauert, Paul A., 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, 12 122.1-122.9. doi:10.1186/1471-2431-12-122

Attached Files (Some files may be inaccessible until you login with your UQ eSpace credentials)
Name Description MIMEType Size Downloads

Author Valery, Patricia C.
Morris, Peter S.
Grimwood, Keith
Torzillo, Paul J.
Byrnes, Catherine A.
Masters, I. Brent
Bauert, Paul A.
McCallum, Gabrielle B.
Mobberly, Charmaine
Chang, Anne B.
Total Author Count Override 10
Title Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial
Journal name BMC Pediatrics   Check publisher's open access policy
ISSN 1471-2431
Publication date 2012-08
Sub-type Article (original research)
DOI 10.1186/1471-2431-12-122
Volume 12
Start page 122.1
End page 122.9
Total pages 9
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2013
Language eng
Formatted 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.
Keyword Azithromycin
Bronchiectasis
Child
Chronic suppurative lung disease
Indigenous health
Placebo
Pulmonary exacerbation
Randomised controlled trial
Antibiotic resistance
Open Access Mandate Compliance Yes - Open Access (Publisher DOI)
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes "Study protocol"

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2013 Collection
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 5 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 7 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Access Statistics: 47 Abstract Views, 0 File Downloads  -  Detailed Statistics
Created: Thu, 15 Nov 2012, 11:28:43 EST by System User on behalf of School of Medicine