Malaria continues to be a significant public health challenge, particularly in Africa, where it has devastating impacts on vulnerable populations, including pregnant women. To address this issue, the Kenya Medical Research Institute (KEMRI) is participating in a groundbreaking trial to find a suitable antimalarial drug for use during the first three months of pregnancy. The trial, which will be conducted in Burkina Faso, Kenya, and Mali, aims to evaluate the efficacy, safety, tolerability, and cost-effectiveness of antimalarial drugs to treat uncomplicated malaria in pregnant women.
The Need for the Trial
Malaria remains a leading cause of morbidity and mortality in Kenya, with approximately 10,000 deaths annually, according to the Ministry of Health. Pregnant women are particularly at risk due to the adverse effects malaria can have on both the mother and the unborn child. These effects include miscarriage, stillbirth, preterm delivery, low birth weight, severe maternal anemia, severe malaria, and maternal mortality.
Despite the significant health risks associated with malaria in pregnancy, women in their first trimester have limited treatment options. Artemisinin-based combination therapies (ACTs) are recommended by the World Health Organization (WHO) as the first-line treatment for malaria. However, only one ACT, artemether-lumefantrine (AL), is recommended for treating uncomplicated malaria during the first trimester.
Emerging drug resistance in several African countries further complicates the situation, necessitating the diversification of ACTs used to treat malaria. This diversification is essential to mitigate resistance but poses the risk of inadvertently exposing pregnant women to drugs other than AL. To address these potential risks, the trial will initially evaluate two treatment arms: pyronaridine-artesunate (PA) with AL serving as the comparator.
The SAFIRE Consortium
The trial is being conducted by the Safety of Antimalarials in the First Trimester (SAFIRE) consortium, which comprises scientific and social research experts in malaria during pregnancy. The consortium’s goal is to generate evidence on the efficacy, safety, and tolerability of antimalarials during the first trimester of pregnancy through an adaptive platform trial and social research.
The results of the trial will inform policy and guidelines on treatment options for malaria in early pregnancy. The enrolment of women in the trial is set to begin in 2025.
Addressing Exclusion from Clinical Trials
Dr. Hellen Barsosio, one of the project’s scientific co-leads and a research scientist in maternal and newborn health at KEMRI, highlighted a significant challenge in malaria treatment for pregnant women: their exclusion from clinical trials. This exclusion is primarily due to concerns about causing harm to the mother and fetus. However, determining which antimalarial medicines are both efficacious and well-tolerated in the first trimester will benefit all women of childbearing age. This includes those who may be unaware they are pregnant, enabling them to take these medicines without risking harm to themselves or their unborn babies.
The Importance of the Trial
Malaria during pregnancy poses significant health risks, yet women in their first trimester have few medicines available for treatment and none for prevention. This trial is crucial in addressing this gap by evaluating the potential of PA and AL in treating uncomplicated malaria during the first trimester.
Pyronaridine-artesunate (PA) is an ACT recommended by WHO for treating malaria in the general population. Preclinical and clinical data generated through ongoing pregnancy registries are reassuring for both mothers and their newborns. The trial will provide more definitive evidence on the safety and efficacy of PA in pregnant women during their first trimester.
Broader Implications
Malaria kills about 10,000 Kenyans every year, underscoring the urgent need for effective treatment options. According to the WHO World Malaria Report 2023, 36% of pregnancies in Africa in 2022 were exposed to malaria, with more than half of these infections occurring before the second trimester. Experts warn that failing to prioritize the prevention and treatment of malaria in early pregnancy could undermine broader malaria elimination efforts.
KEMRI’s involvement in this trial reflects a broader commitment to combating malaria and improving maternal and child health. The trial’s outcomes could lead to significant advancements in the treatment of malaria in pregnant women, potentially saving thousands of lives and reducing the burden of malaria in Kenya and other affected regions.
Financial Incentives and Global Commitment
KEMRI emphasized that there are financial incentives for eliminating malaria, yet the global health community is lagging in its commitment to end malaria by 2030. The trial represents a critical step towards achieving this goal by addressing a key gap in malaria treatment for pregnant women.
In conclusion, the SAFIRE consortium’s trial represents a pivotal effort to find effective and safe treatment options for malaria in the first trimester of pregnancy. By leveraging clinical and social research, the trial aims to better serve women of reproductive age at risk of malaria, ultimately contributing to the global fight against this deadly disease.
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