The LAKANA trial is conducted by a network of researchers from different international organisations:
The principal investigators of the trial are Dr. Per Ashorn (PI – TAU), Dr. Ulla Ashorn (Co-PI – TAU), Dr. Yin-Bun Cheng (Co-PI: Duke-NUS Medical School), Dr. Camilla Ducker (Co-PI: TroDa), Dr. Nigel Klein (Co-PI: UCL) and Dr. Samba Sow (Co-PI: CVD-Mali).
Implementation is overseen by a 5-member Project Steering Group (PSG). The PSG is responsible for overseeing the trial, makes all strategic decisions and reports to the funder and to the Data Safety and Monitoring Board (DSMB). The PSG is composed of the co-PIs from CVD-Mali, TAU, TroDa and UCL.
There are two advisory groups to the study team: A National Advisory Committee (NAC) and an international Technical Advisory Group (TAC). These advise the study team with general study design issues, strategy and progress of the trial.
The scientific and ethical integrity of the trial protocol has been reviewed and approved by an authorised Malian Institutional Review Board (IRB) and by the Malian Ministry of Health.
Data from the LAKANA trial is reviewed regularly by an independent data and safety monitoring board (DSMB) to ensure participant safety. Study procedures, data collection activities, and compliance with good clinical practice (GCP) are also reviewed regularly by an external monitoring company.
The study is funded by the Bill and Melinda Gates Foundation. Study products (azithromycin and placebo) are provided by Pfizer Inc. The trial team gratefully acknowledges the support of both of these organizations.