The trial will assess the safety and efficacy of antimalarial drugs for women in their first trimester of pregnancy. Credit: Primeiya/Shutterstock.

The Safety of Antimalarials in the First Trimester (SAFIRE) consortium has announced plans to undertake a Phase III clinical trial to test antimalarial medicines in early pregnancy.

The trial will assess the safety, tolerability and cost-effectiveness of antimalarial drugs for women in their first trimester of pregnancy, to treat uncomplicated malaria.

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The initiative is supported by the Global Health EDCTP3 Joint Undertaking and the Swiss State Secretariat for Education, Research, and Innovation.

Currently, the World Health Organization recommends only one antimalarial treatment, artemether-lumefantrine (AL), for use in the first trimester of pregnancy.

The SAFIRE trial aims to expand these options by evaluating pyronaridine-artesunate (PA) alongside AL.

The trial’s adaptive platform will also contribute to policy and guidelines.

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Coordinated by the Amsterdam University Medical Center, the consortium includes scientific co-leadership by the University of Sciences, Techniques and Technologies of Bamako (USTTB) and KEMRI.

Medicines for Malaria Venture (MMV) and the Liverpool School of Tropical Medicine will co-sponsor the trial, providing technical input.

The trial will begin in Burkina Faso, Kenya, and Mali. It will commence patient enrolment in 2025, contingent on data from the MiMBa pregnancy registry and PYRAPREG studies.

It is notable for being the first Bayesian adaptive platform trial focused on antimalarial treatments in the first trimester of pregnancy.

The data collected will not only aid in the development of future antimalarial guidelines but also inform trials for other infectious diseases affecting pregnant women in low- and middle-income countries.

In addition to the scientific research, the trial will incorporate social and implementation research.

SAFIRE scientific co-lead and USTTB professor Kassoum Kayentao said: “The trial will provide an evidence base to make an additional ACT available for malaria treatment in the first trimester and also contribute to addressing the lack of equity in enrolling pregnant women in clinical trials.”