Background
infection
ADVERSE EVENTS, INFECTION, SECONDARY, INFLAMMATION
Mass drug administration (MDA) of azithromycin (AZI) is a promising strategy for improving child survival in settings with high under five mortality rates (U5MR) [LAKANA stands for Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin. The primary aim of this trial conducted in Mali, covering 1151 villages, is to evaluate the impact on mortality of two or four annual rounds of AZI MDA delivered to 1–11-month-old infants. The study also includes a range of secondary outcomes such as efficacy outcomes related to morbidity and growth, outcomes related to the mechanism of azithromycin activity through measures of markers of infection and inflammation, safety outcomes (AMR, adverse, and serious adverse events), and outcomes related to the implementation of the intervention documenting feasibility, acceptability, and economic aspects. The LAKANA trial has been registered with ClinicalTrials.gov (NCT04424511) and its protocol (version 4.0, dated 27 June 2022) has been published [