- In a world first, a global consortium plans to undertake a Phase 3 clinical trial assessing antimalarial medicines in women in their first trimester of pregnancy
- The trial will evaluate the efficacy, safety, tolerability and cost-effectiveness of antimalarial drugs to treat uncomplicated malaria
- This pioneering approach challenges the status quo in which pregnant women are typically excluded from clinical trials and addresses a critical gap by focusing on an often-neglected group: women in their first trimester
Kisumu, Kenya and Geneva, Switzerland 10 July 2024. The Safety of Antimalarials in the FIrst TRimEster (SAFIRE) consortium, made up of scientific and social research experts in malaria in pregnancy, has today kicked off the preparation of a historic project: the first-ever Phase 3 clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy.
With financial support from the Global Health EDCTP3 Joint Undertaking (EDCTP3), a partnership funded by African and European countries as well as the European Union, and the Swiss State Secretariat for Education, Research, and Innovation (SERI), SAFIRE will generate robust evidence on the efficacy, safety and tolerability of antimalarials in the first trimester of pregnancy by conducting an adaptive platform trial and social research. Its results will feed into policy and guidelines to ensure that women have optimal treatment options in early pregnancy. The enrolment of women in the trial will start in 2025 pending data from the MiMBa pregnancy registry and PYRAPREG studies.
Dr Hellen Barsosio, one of the project’s scientific co-leads and a Research Scientist of maternal and newborn health at Kenya Medical Research Institute (KEMRI), said “We are thrilled to begin this first-of-its-kind trial. Pregnant women are typically excluded from clinical trials for fear of causing harm to the mother and the baby she is carrying. 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”.