overview
The LAKANA trial (“Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin”, derived from the Bambara meaning “to protect”), was a major cluster-randomized, double-blinded, placebo-controlled, three-arm study conducted in western Mali.
CVD-Mali is proud the work its LAKANA teams conducted, and of the excellent relationships they built in all the project’s communities.
The video above is a brief document of some of the challenges and triumphs they encountered.
It is also a heartfelt thank you to every single member of CVD-Mali’s LAKANA teams for their tirelessness and dedication.
Details
Aim
The trial aimed to assess whether mass drug administration (MDA) of azithromycin – a safe, inexpensive, broad-spectrum antibiotic recommended by the World Health Organization – could reduce high mortality rates among infants aged 1 to 11 months in rural and peri-urban Malian communities. It compared three groups: placebo (control), biannual (two-dose), and quarterly (four-dose) administration regimens.
Design & Scope
Approximately 50,000–60,000 infants across about 1,151 villages in the Kayes, Kita, and Koulikoro regions participated in this 24-month trial, which included eight MDA visits and a final close-out visit. Villages were randomized in a 3:2:4 ratio to control, quarterly, and biannual azithromycin MDA, respectively.
Primary and Secondary Objectives
The primary goal was to determine whether biannual or quarterly azithromycin MDA reduced infant mortality and whether four annual doses were more effective than two.
Secondary objectives included assessing impacts on antimicrobial resistance (AMR) among treated and untreated age groups, infant morbidity and nutritional outcomes, azithromycin’s mechanisms of action, as well as feasibility, safety, and economic considerations.
Timeline & Future Application
Data collection concluded in mid-January 2025, with primary results scheduled for release in 2025/26. The trial was designed to inform policy on the potential expansion of azithromycin MDA as a national public-health intervention in Mali.
Implementation & Oversight
The trial was led by a consortium including the Center for Vaccine Development–Mali (CVD-Mali), Tampere University (Finland), Duke-NUS (Singapore), University College London (UK), and Tro Da Ltd (UK). It was funded by the Bill & Melinda Gates Foundation, with drug supplies donated by Pfizer. Oversight was provided by an independent Data and Safety Monitoring Board (DSMB), a national institutional review board, and the Malian Ministry of Health, ensuring compliance with Good Clinical Practice.
