Trials · 21 authors, 6 centres
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This paper presents the pre-registered statistical analysis plan for the LAKANA cluster-randomized trial, which will evaluate biannual and quarterly azithromycin mass drug administration versus placebo on mortality among 1–11-month-old infants in Mali. No trial results are reported; the document details planned analytic methods to reduce reporting and data-driven analysis bias.
The LAKANA trial is a cluster-randomized, placebo-controlled, double-blinded, parallel-group, three-arm clinical trial conducted in a high-mortality setting in Mali where seasonal malaria chemoprevention is in place. The primary outcome is mortality among the intention-to-treat population, analyzed using a mixed-effects Poisson model with random intercepts for villages and log link with person-years as offset. The SAP aims to improve transparency and reduce reporting bias.
