Skip to main content
. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

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
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
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
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.