Dataset Information

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

ABSTRACT:

Objective

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.

Methods

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.

Results

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.

Conclusion

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.

SUBMITTER: McCallum GB

PROVIDER: S-EPMC3783434 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

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

McCallum Gabrielle B GB Morris Peter S PS Chatfield Mark D MD Maclennan Carolyn C White Andrew V AV Sloots Theo P TP Mackay Ian M IM Chang Anne B AB

PloS one 20130925 9

<h4>Objective</h4>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 resp ...[more]

PMID: 24086334

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Project description:IntroductionPrevious randomised controlled trials (RCTs) suggest antibiotics for treating episodes of asthma-like symptoms in preschool children. Further, high-dose vitamin D supplementation has been shown to reduce the rate of asthma exacerbations among adults with asthma, while RCTs in preschool children are lacking. The aims of this combined RCT are to evaluate treatment effect of azithromycin on episode duration and the preventive effect of high-dose vitamin D supplementation on subsequent episodes of asthma-like symptoms among hospitalised preschoolers.Methods and analysisEligible participants, 1-5 years old children with a history of recurrent asthma-like symptoms hospitalised due to an acute episode, will be randomly allocated 1:1 to azithromycin (10 mg/kg/day) or placebo for 3 days (n=250). Further, independent of the azithromycin intervention participants will be randomly allocated 1:1 to high-dose vitamin D (2000 IU/day+ standard dose 400 IU/day) or standard dose (400 IU/day) for 1 year (n=320). Participants are monitored with electronic diaries for asthma-like symptoms, asthma medication, adverse events and sick-leave. The primary outcome for the azithromycin intervention is duration of asthma-like symptoms after treatment. Secondary outcomes include duration of hospitalisation and antiasthmatic treatment. The primary outcome for the vitamin D intervention is the number of exacerbations during the treatment period. Secondary outcomes include time to first exacerbation, symptom burden, asthma medication and safety.Ethics and disseminationThe RCTs are approved by the Danish local ethical committee and conducted in accordance with the guiding principles of the Declaration of Helsinki. The Danish Medicines Agency has approved the azithromycin RCT, which is monitored by the local Unit for Good Clinical Practice. The vitamin D RCT has been reviewed and is not considered a medical intervention. Results will be published in peer-reviewed journals and presented at international conferences.Trial registration numbersNCT05028153, NCT05043116.

Project description: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.

Dataset Information

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

Objective

Methods

Results

Conclusion

Publications

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

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