Liverpool School of Tropical Medicine (LSTM) is backing the first Phase 3 clinical trial of antimalarial medications for women in their first trimester of pregnancy.
The SAFIRE consortium is leading the trial to assess the effectiveness, safety, and cost of these treatments for uncomplicated malaria. The findings will help shape policies and guidelines, aiming to provide better treatment options for pregnant women in early pregnancy.
SAFIRE is a group of scientists and researchers focused on bridging the evidence gap regarding antimalarial drug use in early pregnancy. Malaria during pregnancy poses serious health risks, including miscarriage, stillbirth, preterm delivery, and low birthweight. Severe cases can also lead to anemia, severe malaria, and maternal death. Yet, women in their first trimester have limited treatment options, with none available for prevention.
The World Health Organization (WHO) recommends artemisinin-based combination therapies (ACTs) as the primary treatment for malaria. As of 2022, only one ACT, artemether-lumefantrine (AL), is approved for use in the first trimester for treating uncomplicated malaria. Although this represents progress towards equal malaria treatment options, drug resistance in some African countries is a growing concern.
This new trial, co-sponsored by Medicines for Malaria Venture and LSTM, will benefit from LSTM’s scientific expertise. The SAFIRE project is coordinated by the Amsterdam University Medical Center, with scientific leadership from the University of Sciences, Techniques and Technologies of Bamako (USTTB) and Kenya Medical Research Institute (KEMRI). It is funded by the Global Health EDCTP3 Joint Undertaking, supported by African and European countries, the European Union, and the Swiss State Secretariat for Education, Research, and Innovation (SERI).
Dr. Hellen Barsosio, a scientific co-lead and Research Scientist in maternal and newborn health at KEMRI, commented: “We are excited to launch this pioneering trial. Pregnant women are often excluded from clinical studies due to concerns about their safety and that of their babies. By finding out which antimalarial drugs are effective and safe during the first trimester, we can ensure that all women, including those who may not yet know they are pregnant, have access to safe treatments.”
The SAFIRE trial will start in Burkina Faso, Kenya, and Mali, and its data will help design future trials for other infectious diseases affecting pregnant women in low- and middle-income countries.
Dr. Stephanie Dellicour, Pharmacoepidemiologist and Principal Investigator at LSTM, added: “We are thrilled to support this groundbreaking trial. It addresses a crucial gap in maternal healthcare and could lead to faster identification of effective and safe treatments for pregnant women at risk of malaria. The results will be crucial for updating malaria treatment guidelines and expanding treatment options.”
