A pragmatic study to assess the efficacy/effectiveness, safety and tolerability of a single day artesunate-pyronaridine plus sulfadoxine-pyrimethamine for the treatment of uncomplicated malaria in adults and children (1-D-CURE / SPAP)

There is an identified need for antimalarial medicines that are simpler and easier to take, such as a single-dose cure (Alonso et al., 2011). Not only would such a medicine facilitate “directly observed therapy”, which would help to prevent the emergence of drug resistance, it would also reduce the cost of treatment (Mischlinger et al., 2016). One of the defined ultimate goal for the development of next-generation antimalarial drugs is to develop a combination of new compounds that block all the stages and are potent enough to work as a curative single-dose, described as a Single Exposure, Radical Cure and Prophylaxis (SERCaP) treatment. This combination will also have to be affordable to the population in need of these drugs (Burrows et al., 2017, 2013; Drugs, 2011). However, a single dose cure can also be considered a pharmacological challenge as the administered dose needs to be excessively high to achieve curative plasma drug concentrations over a sufficient time, accounting for inter-individual differences in bioavailability, ensuring clearance of parasites in patients without significant semi-immunity, such as children, without posing any relevant safety concerns (Mbassi et al., 2023). Combining the current standard antimalarial treatments substantially reduces treatment failure, recrudescence and gametocyte carriage, preventing the emergence and spread of drug resistance and interrupting the transmission of P. falciparum. Coupled with early detection and confirmed diagnosis, this strategy represents one way forward in the chemotherapy of malaria. The triple-ACT strategy is expected to maximise the possibility of a transition to next-generation antimalarials currently under development.

Clinical Trial Id: PACTR202405571736678

Clinical trial details

Drug-based Strategies
Product Development
Vulnerable Populations

May 2024 — Dec 2025

Gabon