AUTHOR=McCallum Gabrielle B. , Morris Peter S. , Grimwood Keith , Maclennan Carolyn , White Andrew V. , Chatfield Mark D. , Sloots Theo P. , Mackay Ian M. , Smith-Vaughan Heidi , McKay Clare C. , Versteegh Lesley A. , Jacobsen Nerida , Mobberley Charmaine , Byrnes Catherine A. , Chang Anne B. 

TITLE=Three-Weekly Doses of Azithromycin for Indigenous Infants Hospitalized with Bronchiolitis: A Multicentre, Randomized, Placebo-Controlled Trial

JOURNAL=Frontiers in Pediatrics

VOLUME=3

YEAR=2015

URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2015.00032

DOI=10.3389/fped.2015.00032

ISSN=2296-2360

ABSTRACT=<sec id="ST1"><title>Background</title><p>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.</p></sec><sec id="ST2"><title>Methods</title><p>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.</p></sec><sec id="ST3"><title>Results</title><p>Two hundred nineteen infants were randomized (<italic>n</italic> = 106 azithromycin, <italic>n</italic> = 113 placebo). No significant between-group differences were found for LOS (median 54 h for each group, difference = 0 h, 95% CI: −6, 8; <italic>p</italic> = 0.8), time receiving oxygen (azithromycin = 40 h, placebo = 35 h, group difference = 5 h, 95% CI: −8, 11; <italic>p</italic> = 0.7), day-21 symptom/signs, or rehospitalization within 6 months (azithromycin <italic>n</italic> = 31, placebo <italic>n</italic> = 25 infants, <italic>p</italic> = 0.2). Azithromycin reduced nasopharyngeal bacterial carriage (between-group difference 0.4 bacteria/child, 95% CI: 0.2, 0.6; <italic>p</italic> &lt; 0.001), but had no significant effect upon virus detection rates.</p></sec><sec id="ST4"><title>Conclusion</title><p>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.</p></sec><sec id="ST5"><title>Clinical trial registration</title><p>The trial was registered with the Australian and New Zealand Clinical Trials Register: Clinical trials number: ACTRN1261000036099.</p></sec>