Beigelman 2015.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 40 children (macrolide n = 20, placebo n = 20) Age in years (mean ± SD): 3.8 ± 2.9 Setting: secondary care |
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Interventions |
Indication: respiratory syncytial virus bronchiolitis Type of macrolide: azithromycin Route: per oral Dose per day: 10 mg/kg once daily for 7 days, followed by 5 mg/kg once daily for an additional 7 days Duration of treatment: 14 days Total treatment dose: N/A |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: yes Adverse events ascertainment: contacting participants' families 3 times a week during the treatment period Adverse events: data reported Antimicrobial resistance: not reported Death: not reported |
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Funding sources | Study supported by Washington University Institute of Clinical and Translational Sciences grant from the National Center for Advancing Translational Sciences and the Children’s Discovery Institute of Washington University and St Louis Children’s Hospital. Supported in part by CTSA grant and Siteman Comprehensive Cancer Center and NCI Cancer Center support grant | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Low risk | Central allocation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical‐appearing placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of all participants, their families, investigators, and study staff |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 child lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Adverse events stated as an outcome, standardised ascertainment and adverse events reported. |
Other bias | Low risk | None were identified. |