An unnamed number of Kenyan women will take part in a trial to find the appropriate drug to treat malaria in the first three months of pregnancy.
“The trial will evaluate the efficacy, safety, tolerability and cost-effectiveness of antimalarial drugs to treat uncomplicated malaria,” the Kenya Medical Research Institute, which is taking part in the trial, said in a statement.
The exercise will be conducted by Safety of Antimalarials in the FIrst TRimEster (SAFIRE) consortium, made up of scientific and social research experts in malaria in pregnancy.
Kemri said SAFIRE will generate evidence on the efficacy, safety and tolerability of antimalarials in the first trimester of pregnancy by conducting an adaptive platform trial and social research.
The results will feed into policy and guidelines on the treatment options in early pregnancy.
The enrolment of women in the trial will start in 2025.
Dr Hellen Barsosio, one of the project’s scientific co-leads and a research scientist of maternal and newborn health at Kemri, said pregnant women are typically excluded from clinical trials for fear of causing harm to the mother and the foetus.
“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 Barsosio said.
She said despite the significant health risks associated with malaria in pregnancy — such as miscarriage, stillbirth, preterm delivery and low birthweight, severe maternal anaemia, severe malaria and maternal mortality — women in their first trimester are left with few medicines for treatment (and none for prevention).
Artemisinin-based combination therapies (ACTs) are the first-line malaria treatment recommended by WHO.
However, there is only one ACT, artemether-lumefantrine (AL), recommended for use as of 2022 to treat uncomplicated malaria in the first trimester.
However, Kemri said emerging drug resistance in several African countries is now a major concern.
The institute said one method of resistance mitigation is to diversify the ACTs used to treat malaria.
“However, this may result in inadvertently exposing women in their first trimester to drugs other than AL. To proactively address potential risks, the trial will initially evaluate two treatment arms: pyronaridine-artesunate (PA) with the widely used AL serving as the comparator,” it said in a statement.
“PA is an ACT recommended by WHO to treat malaria in the general population. To date, preclinical data and clinical data generated for the medicine through ongoing pregnancy registries are reassuring for both mothers and their newborns.”
The trial will be conducted in Burkina Faso, Kenya and Mali.
Malaria kills about 10,000 Kenyans every year, according to the Ministry of Health.
Kemri said there are financial incentives for eliminating malaria, yet the global health community is behind on its commitment to end malaria by 2030.
According to WHO World Malaria Report released in 2023, 36 per cent of the pregnancies in Africa in 2022 were exposed to malaria
More than half of malaria infections during pregnancy are estimated to occur before the second trimester. Experts have warned that failing to prioritise the prevention and treatment of malaria in early pregnancy could harm broader malaria elimination efforts.