Frontiers in Pediatrics (Apr 2015)

Three-weekly doses of azithromycin for Indigenous infants hospitalised with bronchiolitis: A multicentre, randomised, placebo-controlled trial

  • Gabrielle Britt McCallum,
  • Peter S Morris,
  • Peter S Morris,
  • Keith eGrimwood,
  • Carolyn eMaclennan,
  • Andrew V White,
  • Mark D Chatfield,
  • Theo P Sloots,
  • Ian M Mackay,
  • Ian M Mackay,
  • Heidi eSmith-Vaughan,
  • Clare C Mckay,
  • Lesley A Versteegh,
  • Nerida eJacobsen,
  • Charmaine eMobberley,
  • Catherine Ann Byrnes,
  • Anne B Chang,
  • Anne B Chang

DOI
https://doi.org/10.3389/fped.2015.00032
Journal volume & issue
Vol. 3

Abstract

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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 hospitalisation period. In an international, double-blind randomised controlled trial, we determined if 3-weeks of azithromycin, improved clinical outcomes in Indigenous infants hospitalised with bronchiolitis. Methods Infants aged ≤24-months were enrolled from three centres and randomised to receive three once-weekly doses of either azithromycin (30mg/kg) or placebo. Nasopharyngeal swabs were collected at baseline and 48-hours later. Primary endpoints were hospital length of stay (LOS) and duration of oxygen supplementation monitored every 12-hours until judged ready for discharge. Secondary outcomes were: day-21 symptom/signs, respiratory rehospitalisations within 6-months post-discharge and impact upon nasopharyngeal bacteria and virus shedding at 48-hours. Results Two-hundred-and-nineteen infants were randomised (n=106 azithromycin, n=113 placebo). No significant between-group differences were found for LOS (median 54-hours for each group, difference=0-hours, 95%CI: -6, 8; p=0.8), time receiving oxygen (azithromycin=40-hours, placebo=35-hours, group difference=5-hours, 95%CI: -8, 11; p=0.7), day-21 symptom/signs or rehospitalisation within 6-months (azithromycin n=31, placebo=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. ConclusionDespite 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-hospitalisation. Azithromycin should not be used routinely to treat infants hospitalised with bronchiolitis. Clinical trial registration The trial was registered with the Australian and New Z

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