The Safety of Antimalarials in the FIrst TRimEster (SAFIRE) consortium, an African-European partnership, will start Phase 3 clinical trial of antimalarials in early pregnancy.
The world’s first global project will conduct a trial to assess the efficacy and safety of antimalarial medicines in women in their first trimester of pregnancy.
SAFIRE consortium consists of several scientific and social research experts in malaria in pregnancy.
The partnership is supported financially by the Global Health EDCTP3 Joint Undertaking (EDCTP3), a collaboration funded by African and European countries along with the European Union, and the Swiss State Secretariat for Education, Research, and Innovation (SERI).
The late-stage study will evaluate how effective, safe, tolerable, and cost-effective antimalarial drugs are in treating uncomplicated malaria.
It will be achieved through an adaptive platform trial and complementary social research.
The trial outcomes will support in devising policy and guidelines, ensuring optimal treatment options for women in early pregnancy.
Enrolment of participants is scheduled to start in 2025, subject to data from the MiMBa pregnancy registry and PYRAPREG studies.
Project scientific co-leads and Kenya Medical Research Institute maternal and newborn health Research Scientist Hellen Barsosio said: “Determining which antimalarial medicines are efficacious and well tolerated in the first trimester will benefit all women of childbearing age, including those who may be unaware that they are pregnant, by enabling them to take these medicines without risk of causing harm to themselves or their unborn babies.”
The Phase 3b clinical trial, co-sponsored by Medicines for Malaria Venture (MMV) and the Liverpool School of Tropical Medicine (LSTM), will involve Bayesian adaptive platform methodology to evaluate the efficacy, safety, and tolerability of these treatments in the first trimester of pregnancy.
Beginning in Burkina Faso, Kenya, and Mali, the move will generate essential data that can inform the design of future trials of pregnant women in low- and middle-income countries.
Furthermore, representatives from participating institutions will spearhead formative research, an initial phase to refine the trial’s design.
It will focus on identifying culturally appropriate methods for participant identification, recruitment, and retention throughout the trial process.
