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Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian
Anne B Chang1, Keith Grimwood, Andrew V White
1Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia. annechang@ausdoctors.net
Insights
This study investigated azithromycin for Indigenous infants with bronchiolitis, aiming to reduce respiratory illness morbidity. Results will determine if this antibiotic improves outcomes for high-risk infants.
Area of Science:
- Pediatric infectious diseases
- Respiratory medicine
- Indigenous health
Background:
- Acute lower respiratory infections cause significant morbidity and mortality in Indigenous infants.
- Bronchiolitis, a common infancy infection, is more severe in Indigenous Australian infants.
- Early airway injury may increase the risk of chronic pulmonary disorders.
Purpose of the Study:
- To test if azithromycin improves clinical outcomes in Indigenous Australian infants hospitalized with bronchiolitis.
- To evaluate the antimicrobial and anti-inflammatory effects of azithromycin in this population.
- To assess the potential for azithromycin to reduce short- and long-term respiratory illness morbidity.
Main Methods:
- A dual-centre, randomized, double-blind, placebo-controlled trial involving 200 Indigenous infants (≤24 months) with bronchiolitis.
- Participants received weekly azithromycin or placebo for three doses.
- Primary outcomes included length of oxygen requirement and duration of hospital stay; secondary outcome was 6-month readmission for respiratory illness.
Main Results:
- Data collection is ongoing; results are pending.
- The study will report descriptive virological and bacteriological data, including antibiotic resistance.
- Analysis will focus on comparing outcomes between the azithromycin and placebo groups.
Conclusions:
- Conflicting results exist from previous studies on macrolides for bronchiolitis.
- This trial aims to definitively determine azithromycin's efficacy in reducing morbidity in high-risk Indigenous infants.
- Positive findings could lead to improved short- and long-term health benefits for Indigenous infants.
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 enrollment 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.
