Keenan 2018.
Methods | Design: cluster‐randomised placebo‐controlled trial | |
Participants |
Number assigned: 1533 communities (macrolide n = 767 communities (97,047 children), placebo n = 766 communities (93,191 children), excluded n = 20 communities, declined n = 1 community) Age in months (range): 1 to 59 Setting: communities in Malawi, Niger, and Tanzania |
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Interventions |
Indication: mass distribution of antibiotics to reduce mortality Type of macrolide: azithromycin Route: per oral Dose: minimum 20 mg/kg once. Repeated twice yearly Duration of treatment: 4 years Total treatment dose: N/A |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: unclear Ascertainment of adverse events: parents asked Adverse event: data reported Antimicrobial resistance: not reported Death: data reported |
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Funding sources | Supported by a grant from the Bill & Melinda Gates Foundation. Pfizer provided both the azithromycin and the placebo. | |
Notes | Concomitant medication: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central 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 participants, observers, and investigators |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for exclusion of 20 communities explained, no communities were lost to follow‐up after the initial census. |
Selective reporting (reporting bias) | High risk | Unclear if adverse events were stated as an outcome, standardised ascertainment. Report on very few adverse events in a large trial population |
Other bias | Low risk | None were identified. |