LAKANA trial A research plan for a cluster-randomized, double-blinded, parallel group, controlled trial, testing the effects of mass-drug administration of azithromycin on mortality and other outcomes among 1-11 month old infants in rural Mali Principal and co-principal investigators (in alphabetical order) Per Ashorn, MD, PhD 1 Ulla Ashorn, PhD 1 Yin Bun Cheung, PhD 1,2 Camilla Ducker, MBBS, MSc 3 Nigel Klein, MBBS, PhD 4 Samba O Sow, MD, MSc, FASTMH 5 Participating Academic Institutions 1Center for Child Health Research, Tampere University, Faculty of Medicine and Health Technology, Tampere, Finland 2Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore 3Tro Da Ltd, UK 4University College London, UK 5CVD-Mali, Bamako, Mali Contact information: Per Ashorn, MD, PhD, Center for Child Health Research, Tampere University, Faculty of Medicine and Health Technology, Tampere Finland Tel. +358 40 7280 345, E-mail:
[email protected] Protocol version 2.0: 17. December 2019 Trial protocol: LAKANA Page 2 / 89 Table of contents 1. PROTOCOL VERSION HISTORY ...................................................................... 4 2. EXECUTIVE SUMMARY ..................................................................................... 5 2.01. ADMINISTRATIVE INFORMATION ........................................................................ 5 2.02. KEY DETAILS OF THE TRIAL ................................................................................ 6 3. BACKGROUND ....................................................................................................