Trial design.
The MORDOR (Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance) trial is a cluster-randomized trial administered in 3 African countries—Niger, Malawi, and Tanzania. Randomization occurred at the village level, and mortality rates for children aged 1 to 59 months were evaluated according to whether the village’s children received azithromycin or placebo every 6 months for 4 years (8 doses overall). Across all study countries, 1,533 villages were randomized into azithromycin or placebo arms, and 190,238 children were enrolled.In Niger, 15 villages from each study arm (30 total villages) were randomly assigned to be additionally evaluated for resistance morbidity, and resistance was evaluated posttreatment initiation at three time points: 12, 24, and 36 months. The complete MORDOR protocol and CONSORT metrics are available in the Numbers of nasopharyngeal swabs and Community and participant flow for trial intervention and antimicrobial resistance assessment at 36 months.