A single dose of azithromycin does not improve clinical outcomes of children hospitalised with bronchiolitis: a randomised, placebo-controlled trial

Bronchiolitis, one of the most common reasons for hospitalisation in young children, is particularly problematic in Indigenous children. Macrolides may be beneficial in settings where children have high rates of nasopharyngeal bacterial carriage and frequent prolonged illness. The aim of our double-...

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Bibliographic Details
Published in:	PloS one 2013-09, Vol.8 (9), p.e74316-e74316
Main Authors:	McCallum, Gabrielle B, Morris, Peter S, Chatfield, Mark D, Maclennan, Carolyn, White, Andrew V, Sloots, Theo P, Mackay, Ian M, Chang, Anne B
Format:	Article
Language:	eng
Subjects:	Anti-Bacterial Agents - therapeutic use Antibiotics Azithromycin Azithromycin - therapeutic use Bacteria Bacterial infections Bronchiolitis Bronchiolitis - drug therapy Bronchopneumonia Children Children & youth Childrens health Clinical outcomes Clinical trials Comparative analysis Double-Blind Method Ethics Family medical history Female Health services Hospitals Humans Indigenous peoples Infant Infections Infectious diseases Laboratories Length of Stay Male Medical research Microbiology Oxygen Patient outcomes Placebos Pneumonia Randomization Respiratory syncytial virus Viruses
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Summary:	Bronchiolitis, one of the most common reasons for hospitalisation in young children, is particularly problematic in Indigenous children. Macrolides may be beneficial in settings where children have high rates of nasopharyngeal bacterial carriage and frequent prolonged illness. The aim of our double-blind placebo-controlled randomised trial was to determine if a large single dose of azithromycin (compared to placebo) reduced length of stay (LOS), duration of oxygen (O2) and respiratory readmissions within 6 months of children hospitalised with bronchiolitis. We also determined the effect of azithromycin on nasopharyngeal microbiology. Children aged ≤18 months were randomised to receive a single large dose (30 mg/kg) of either azithromycin or placebo within 24 hrs of hospitalisation. Nasopharyngeal swabs were collected at baseline and 48 hrs later. Primary endpoints (LOS, O2) were monitored every 12 hrs. Hospitalised respiratory readmissions 6-months post discharge was collected. 97 children were randomised (n = 50 azithromycin, n = 47 placebo). Median LOS was similar in both groups; azithromycin = 54 hours, placebo = 58 hours (difference between groups of 4 hours 95%CI -8, 13, p = 0.6). O2 requirement was not significantly different between groups; Azithromycin = 35 hrs; placebo = 42 hrs (difference 7 hours, 95%CI -9, 13, p = 0.7). Number of children re-hospitalised was similar 10 per group (OR = 0.9, 95%CI 0.3, 2, p = 0.8). At least one virus was detected in 74% of children. The azithromycin group had reduced nasopharyngeal bacterial carriage (p = 0.01) but no difference in viral detection at 48 hours. Although a single dose of azithromycin reduces carriage of bacteria, it is unlikely to be beneficial in reducing LOS, duration of O2 requirement or readmissions in children hospitalised with bronchiolitis. It remains uncertain if an earlier and/or longer duration of azithromycin improves clinical and microbiological outcomes for children. The trial was registered with the Australian and New Zealand Clinical Trials Register. Clinical trials number: ACTRN12608000150347. http://www.anzctr.org.au/TrialSearch.aspx.
ISSN:	1932-6203 1932-6203