The SAFIRE consortium, led by Medicines for Malaria Venture (MMV) and the Liverpool School of Tropical Medicine, is set to initiate a Phase III clinical trial focused on assessing the safety and efficacy of antimalarial drugs during early pregnancy. Named the Safety of Antimalarials in the First Trimester (SAFIRE) trial, this initiative aims to expand treatment options for uncomplicated malaria in pregnant women, specifically targeting those in their first trimester.
Supported by the Global Health EDCTP3 Joint Undertaking and the Swiss State Secretariat for Education, Research, and Innovation, the trial will compare the widely recommended artemether-lumefantrine (AL) with pyronaridine-artesunate (PA). These evaluations will take place under the auspices of the Amsterdam University Medical Center, with scientific co-leadership from the University of Sciences, Techniques and Technologies of Bamako (USTTB) and KEMRI.
Commencing patient enrollment in 2025 across Burkina Faso, Kenya, and Mali, the trial’s launch hinges on data from the MiMBa pregnancy registry and PYRAPREG studies. Notably, this marks the first Bayesian adaptive platform trial focused on antimalarial treatments during early pregnancy.
Professor Kassoum Kayentao from USTTB emphasized the trial’s potential impact: “The SAFIRE trial will establish an evidence base to introduce an additional ACT for malaria treatment in the first trimester, addressing the current disparities in clinical trial inclusion among pregnant women.”
Beyond its scientific objectives, the trial will integrate social and implementation research, aiming to influence future guidelines and trials concerning infectious diseases affecting pregnant women in low- and middle-income nations.
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