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November 24, 2025
2 min read
Key takeaways:
- Researchers treated patients with uncomplicated malaria with a single dose of a four-drug combination treatment.
- It was non-inferior to the standard 3-day, multi-dose treatment.
A single dose of a four-drug combination therapy for uncomplicated malaria was just as effective as the multi-day standard of care treatment, according to data presented at the American Society of Tropical Medicine & Hygiene Annual Meeting.
“The study was prompted by two threats identified for the treatment of malaria: one is the development of resistance by the parasite, the second one is the poor compliance by the patients to the several doses given over 3 days,” Ghyslain Mombo-Ngoma, MD, PhD, head of clinical operations at the Medical Research Center of Lambaréné, also known as CERMEL,, told Healio.
“To tackle these threats, we have explored two strategies — one is the use of a single-dose to address compliance issues (most next-generation antimalarial drugs under development are targeting single-dose), the other one is the use of multidrug combination therapy, a strategy that is being evaluated at the same time with existing medicines and with next-generation drugs for malaria, while already used for other infectious diseases such as tuberculosis and HIV/AIDS,” Mombo-Ngoma continued.
He further explained that his goal was to make the most of existing drugs as multidrug combination single-dose therapy, while awaiting the next-generation single-dose treatments that he said are in the pipeline and might be available within 7 to 10 years.
To assess the efficacy and safety of a multidrug treatment option, the researchers conducted a comparative, randomized, non-inferiority trial during which patients — both adults and children — with uncomplicated malaria were randomly assigned 1:1 to receive a single dose of sulfadoxine-pyrimethamine plus artesunate-pyronaridine (SPAP) or a standard treatment course of artemether-lumefantrine (AL).
According to Mombo-Ngoma, SPAP was chosen after the researchers screened existing antimalarial treatments and determined it may be more effective against drug-resistant parasites due to the four-drug combination than standard therapies. He also said in a press release that standard treatment typically requires taking six doses over 3 days, “which many patients never complete.”
The primary efficacy endpoint of the study was adequate clinical and parasitological response (ACPR) — being parasite-free or cured — at day 28.
Between May 2024 and October 2025, more than 1,000 patients were screened 981 were enrolled and ultimately treated, with 539 (55%) receiving SPAP and 442 (45%) receiving AL. Bloodwork on day 28 showed that ACPR was 93% among patients who received SPAP and 90% for those who received AL.
The researchers also found that adverse events were generally mild to moderate in severity and brief, and that serious adverse events reported during the study were not related to the treatment drugs.
Based on these findings, Mombo-Ngoma said that while a single-dose malaria treatment is the ultimate goal for next-generation antimalarial drugs, these data show that “we can make the most of existing antimalarial drugs, particularly SPAP,” which can effectively be used as a single-dose treatment.
“Regarding the stall in malaria morbidity and mortality, that single-dose therapy may contribute to saving more lives and provide implementation lessons that will be helpful when the next-generation drugs become available,” he said.
Looking ahead, Mombo-Ngoma said the goal is to have at least 1,000 patients take part in the study. Beyond that, he said the plan is to conduct a large-scale implementation study in different settings in sub-Saharan Africa including Mali, Ghana, Gabon, Congo, Kenya and Mozambique.
For more information:
Ghyslain Mombo-Ngoma, MD, PhD, can be reached at ghyslain.mombongoma@cermel.org.
Sources/Disclosures
Source:
Mombo-Ngoma G, et al. Efficacy, safety and tolerability of a single dose sulfadoxine-pyrimethamine plus artesunate-pyronaridine (SPAP) for the treatment of uncomplicated malaria in adults and children in Gabon: the 1-DCURE study — a pragmatic randomized controlled clinical trial. Presented at: American Society of Tropical Medicine & Hygiene Annual Meeting; Nov. 9-13, 2025; Toronto.
Reference:
- Clinical trial in Africa finds single-dose malaria treatment combining four existing drugs as effective as more onerous multi-day, multi-dose regimen. https://www.eurekalert.org/news-releases/1104246. Published Nov. 12, 2025. Accessed Nov. 17, 2025.
Disclosures:
Mombo-Ngoma reports no relevant financial disclosures.
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