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Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled
Patricia C Valery1, Peter S Morris, Keith Grimwood
1Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia. patricia.valery@menzies.edu.au
Insights
This study investigated if weekly azithromycin reduces lung exacerbations in Indigenous children with bronchiectasis. Results will inform long-term antibiotic use for this condition.
Area of Science:
- Pediatric Pulmonology
- Infectious Diseases
- Clinical Trials
Background:
- High prevalence of chronic suppurative lung disease (CSLD) and bronchiectasis in Indigenous children across Australia, New Zealand, and Alaska.
- Antibiotics are a cornerstone of CSLD management, with long-term use aimed at reducing pulmonary exacerbations.
- Limited evidence exists on the efficacy of long-term antibiotic therapy for pediatric CSLD and non-cystic fibrosis bronchiectasis.
Purpose of the Study:
- To test the hypothesis that weekly maintenance azithromycin reduces pulmonary exacerbations in Indigenous children with bronchiectasis.
- To provide evidence supporting the use of long-term antibiotics for managing bronchiectasis in this vulnerable population.
Main Methods:
- Multicenter, randomized, double-blind, placebo-controlled trial in Australia and New Zealand.
- Inclusion of Indigenous children aged 1-8 years with diagnosed bronchiectasis and at least one exacerbation in the past year.
- Randomization to weekly azithromycin (30 mg/kg) or placebo for 12-24 months, with primary outcomes being exacerbation rate and time to exacerbation.
Main Results:
- Primary outcomes: rate and time to pulmonary exacerbations.
- Secondary outcomes: exacerbation severity, growth, school absenteeism, respiratory symptoms, lung function (FEV1), and sputum characteristics.
- Safety endpoints include serious adverse events and monitoring of antibiotic resistance.
Conclusions:
- The trial aims to determine the efficacy of azithromycin in reducing pulmonary exacerbations.
- Positive findings would establish a rationale for long-term antibiotic use in pediatric bronchiectasis management for Indigenous children.
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 (FEV(1); 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.
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