Three-weekly doses of azithromycin for indigenous infants hospitalized with bronchiolitis: a multicentre, randomized,
Gabrielle B McCallum1, Peter S Morris2, Keith Grimwood3
1Child Health Division, Menzies School of Health Research, Charles Darwin University , Darwin, NT , Australia.
Insights
Three weeks of azithromycin did not improve clinical outcomes for infants hospitalized with bronchiolitis. The antibiotic reduced bacterial carriage but did not affect illness duration or rehospitalization rates.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Trials
Background:
- Bronchiolitis poses a significant global health burden, especially for Indigenous infants.
- The efficacy of azithromycin in improving clinical outcomes post-hospitalization for bronchiolitis remains unclear.
- This study investigated azithromycin's impact on Indigenous infants hospitalized with bronchiolitis.
Purpose of the Study:
- To determine if a 3-week course of azithromycin improves clinical outcomes in Indigenous infants hospitalized with bronchiolitis.
- To assess the effect of azithromycin on length of stay and oxygen requirement.
- To evaluate secondary outcomes including symptom duration and rehospitalization rates.
Main Methods:
- An international, double-blind, randomized controlled trial involving infants aged ≤24 months.
- Participants received three once-weekly doses of azithromycin (30 mg/kg) or placebo.
- Primary endpoints included hospital length of stay and duration of oxygen supplementation; secondary outcomes assessed symptoms, rehospitalizations, and microbial shedding.
Main Results:
- No significant differences were observed between azithromycin and placebo groups for length of stay or oxygen duration.
- Secondary outcomes, including day-21 symptoms and 6-month rehospitalization rates, showed no significant improvement with azithromycin.
- Azithromycin significantly reduced nasopharyngeal bacterial carriage but did not impact virus detection rates.
Conclusions:
- A 3-week course of azithromycin did not provide clinical benefits for infants hospitalized with bronchiolitis compared to placebo.
- While azithromycin reduced bacterial carriage, it did not improve illness course or reduce rehospitalizations.
- Routine use of azithromycin for hospitalized infants with bronchiolitis is not recommended.
Background:
Bronchiolitis is a major health burden in infants globally, particularly among Indigenous populations. It is unknown if 3 weeks of azithromycin improve clinical outcomes beyond the hospitalization period. In an international, double-blind randomized controlled trial, we determined if 3 weeks of azithromycin improved clinical outcomes in Indigenous infants hospitalized with bronchiolitis.
Methods:
Infants aged ≤24 months were enrolled from three centers and randomized to receive three once-weekly doses of either azithromycin (30 mg/kg) or placebo. Nasopharyngeal swabs were collected at baseline and 48 h later. Primary endpoints were hospital length of stay (LOS) and duration of oxygen supplementation monitored every 12 h until judged ready for discharge. Secondary outcomes were: day-21 symptom/signs, respiratory rehospitalizations within 6 months post-discharge and impact upon nasopharyngeal bacteria and virus shedding at 48 h.
Results:
Two hundred nineteen infants were randomized (n = 106 azithromycin, n = 113 placebo). No significant between-group differences were found for LOS (median 54 h for each group, difference = 0 h, 95% CI: -6, 8; p = 0.8), time receiving oxygen (azithromycin = 40 h, placebo = 35 h, group difference = 5 h, 95% CI: -8, 11; p = 0.7), day-21 symptom/signs, or rehospitalization within 6 months (azithromycin n = 31, placebo n = 25 infants, p = 0.2). Azithromycin reduced nasopharyngeal bacterial carriage (between-group difference 0.4 bacteria/child, 95% CI: 0.2, 0.6; p < 0.001), but had no significant effect upon virus detection rates.
Conclusion:
Despite reducing nasopharyngeal bacterial carriage, three large once-weekly doses of azithromycin did not confer any benefit over placebo during the bronchiolitis illness or 6 months post hospitalization. Azithromycin should not be used routinely to treat infants hospitalized with bronchiolitis.
Clinical Trial Registration:
The trial was registered with the Australian and New Zealand Clinical Trials Register: Clinical trials number: ACTRN1261000036099.
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