By Joyce Ojanji
A global consortium of scientific and social research experts in malaria from Africa and Europe has started Phase III clinical trials to assess the efficacy and safety of antimalarials in women during the first trimester of pregnancy.
The Safety of Antimalarials in the First Trimester (SAFIRE) consortium, coordinated by the Amsterdam University Medical Center, the University of Sciences, Techniques and Technologies of Bamako (USTTB), and the Kenya Medical Research Institute (KEMRI), was formed to address the evidence gap in the use of antimalarial drugs in early pregnancy.
“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. 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,” Dr. Hellen Barsosio, a specialist in maternal and newborn health at KEMRI, Dr. Barsosio is one of the project’s scientific co-leads.
Despite significant health risks associated with malaria in pregnancy, such as miscarriage, stillbirth, preterm delivery and low birth weight, severe malaria, and maternal mortality, women in their first trimester have limited options, with just one medicine for malaria treatment and none for prevention.
According to the consortium, artemisinin-based combination therapies (ACTs) are the first-line malaria treatment recommended by the WHO. However, as of 2022, only one ACT, artemether-lumefantrine (AL), is recommended to treat uncomplicated malaria in the first trimester. Although this is a significant step towards achieving equity in malaria treatment choice, emerging drug resistance in several African countries is now a significant concern.
The Phase III clinical trials will enroll women across Burkina Faso, Kenya, and Mali. The study is expected to generate robust evidence on the efficacy, safety, and tolerability of antimalarials in the first trimester of pregnancy. Its results will feed into policy and guidelines to ensure women have optimal early pregnancy treatment options.
“There is an urgent need to provide alternative therapeutic options in this susceptible phase of pregnancy. 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,” explains Prof. Kassoum Kayentao of USTTB.
The researchers will use formative research to inform the final trial design and determine culturally appropriate methods for identifying, recruiting, and retaining participants throughout the trial.
According to Maud Majeres Lugand, Associate Director of Social Research at MMV, “Engaging with the community to build trust and understand possible recruitment barriers like cultural sensitivities as well as women’s concerns about taking medicines in early pregnancy, will be crucial for an ethical and successful enrolment of women in the clinical study.”
The project is funded by the Global Health EDCTP3 Joint Undertaking (EDCTP3), a partnership funded by African and European countries, the European Union, and the Swiss State Secretariat for Education, Research, and Innovation (SERI). Medicines for Malaria Venture (MMV) and the Liverpool School of Tropical Medicine (LSTM) co-sponsor the Phase III b clinical trial.
“Malaria during pregnancy can cause serious maternal and newborn health issues. That is why we support this crucial project, SAFIRE, with over €5 million,” said Dr Michael Makanga, Executive Director of Global Health EDCTP3.
