Evaluating Safety and Effectiveness of New Antimalarial Treatments Compared to Standard Care in Pregnant Women During the First Trimester

What this Trial Is About

Researchers are evaluating the safety and effectiveness of antimalarial drugs for treating uncomplicated malaria during the first trimester of pregnancy, a critical period for both mother and baby. The study compares the current standard treatment, artemether-lumefantrine AL, with newer antimalarials like pyronaridine-artesunate PA and dihydroartemisinin-piperaquine DP that have shown promise in earlier studies. The goal is to confirm if these newer drugs work as well as AL and are safe for pregnancy outcomes, while offering benefits such as simpler dosing and longer protection against new infections. The trial uses a Bayesian Adaptive Platform design that allows adding new treatments over time and stopping arms early if safety concerns arise. Pregnant women diagnosed with uncomplicated malaria in their first trimester are randomly assigned to receive AL twice daily for 3 days, or PA or DP once daily for 3 days with weight-based dosing. The study is open-label and conducted in multiple African countries where malaria is common. Participants will be monitored closely with daily visits for 4 days, weekly visits for 6 weeks, followed by monthly visits until delivery. Health and pregnancy outcomes will be tracked, and newborns followed for 6 months after birth. Safety data will be reviewed regularly by an independent monitoring board. The primary measure of success is the clinical and parasitological response at day 42. This research aims to expand safe treatment options for malaria in early pregnancy and improve health outcomes for mothers and babies in malaria-affected regions.

Safety of Antimalarials in the FIRst trimEster