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Open Access Study protocol

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

Patricia C Valery1*, Peter S Morris12, Keith Grimwood34, Paul J Torzillo5, Catherine A Byrnes67, I Brent Masters38, Paul A Bauert2, Gabrielle B McCallum1, Charmaine Mobberly67 and Anne B Chang138

Author Affiliations

1 Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia

2 Department of Paediatrics, Royal Darwin Hospital, Darwin, Darwin, NT, Australia

3 Queensland Children’s Medical Research Institute, The University of Queensland, Brisbane, QLD, Australia

4 Queensland Paediatric Infectious Diseases Laboratory, Royal Children’s Hospital, Brisbane, QLD, Australia

5 Royal Prince Alfred Hospital, and University of Sydney, Sydney, Australia

6 Department of Paediatrics, University of Auckland, Auckland, New Zealand

7 Paediatric Respiratory Medicine, Starship Children’s Health, Auckland, New Zealand

8 Queensland Children’s Respiratory Centre, Royal Children’s Hospital, Brisbane, QLD, Australia

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BMC Pediatrics 2012, 12:122  doi:10.1186/1471-2431-12-122

Published: 14 August 2012

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.

Trial registration

Australian New Zealand Clinical Trials Registry: ACTRN12610000383066

Keywords:
Azithromycin; Bronchiectasis; Child; Chronic suppurative lung disease; Indigenous health; Placebo; Pulmonary exacerbation; Randomised controlled trial; Antibiotic resistance