Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
The LAKANA trial will assess the impact on mortality and other health outcomes of quarterly
and biannual azithromycin mass drug administration (MDA) when delivered to 1-11-month old
infants in a high-mortality setting where malaria is holoendemic but there is also a
functioning seasonal malaria chemoprevention (SMC) program in place. The long-term goal is to
more precisely define the role of mass azithromycin treatments as an intervention for
reducing childhood mortality, and to determine the most effective treatment regimen. The main
study hypotheses in terms of mortality effect are: i) Biannual azithromycin MDA to 1-11 month
old infants reduces their mortality, ii) Quarterly azithromycin MDA to 1-11 month old infants
reduces their mortality, iii) Quarterly azithromycin MDA has a bigger mortality effect than
biannual MDA.
Phase:
Phase 3
Details
Lead Sponsor:
Tampere University
Collaborators:
Bill and Melinda Gates Foundation Bill and Melinda Gates Foundation (Funder) Center for Vaccine Development CVD-Mali, Bamako, Mali Duke-NUS Graduate Medical School Pfizer Inc. (Provider of study drugs) Tro Da Ltd, UK University College London Hospitals University College London, UK.