NAIROBI, Kenya – In a move to safeguard maternal and child health, Kenya is set to participate in an innovative trial aimed at identifying the most effective antimalarial treatment for pregnant women in their first trimester.
This trial, a collaborative effort by the Safety of Antimalarials in the First Trimester (SAFIRE) consortium, will evaluate the efficacy, safety, and cost-effectiveness of various antimalarial drugs.
The Kenya Medical Research Institute (Kemri), a key player in the trial, emphasized the study’s importance in a recent statement: “The trial will evaluate the efficacy, safety, tolerability and cost-effectiveness of antimalarial drugs to treat uncomplicated malaria.”
This initiative, which is set to begin enrolling participants in 2025, will be conducted across Kenya, Burkina Faso, and Mali.
Malaria poses significant risks to pregnant women, including miscarriage, stillbirth, preterm delivery, low birth weight, severe maternal anemia, severe malaria, and maternal mortality.
“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 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 scientific co-lead of the project and a research scientist in maternal and newborn health at Kemri, highlighted the critical need for this research.
Currently, the World Health Organization (WHO) recommends only one artemisinin-based combination therapy (ACT), artemether-lumefantrine (AL), for treating uncomplicated malaria in the first trimester.
However, emerging drug resistance in several African countries necessitates the exploration of alternative treatments.
The SAFIRE trial will initially focus on comparing pyronaridine-artesunate (PA), another WHO-recommended ACT, with AL. Preclinical and clinical data suggest that PA is safe for both mothers and their newborns.
The trial’s findings are expected to inform global health policies and treatment guidelines, potentially transforming malaria treatment protocols for pregnant women.
With malaria responsible for approximately 10,000 deaths annually in Kenya alone, the stakes are high.
The 2023 WHO World Malaria Report revealed that 36% of pregnancies in Africa in 2022 were exposed to malaria, underscoring the urgent need for effective early pregnancy interventions.
Kemri pointed out that eliminating malaria would bring substantial financial benefits, yet the global health community remains behind on its commitment to eradicate the disease by 2030.