Study of Artesunate Drug Levels in Infants Treated for Severe Malaria Under 2 Years Old

What this Trial Is About

This research focuses on infants under 2 years old being treated for severe malaria. It is an add-on laboratory study to a larger ongoing observational study called ARTEMUM, which examines the safety and effectiveness of artesunate in pregnant women and infants. The study aims to measure the levels of artesunate and its active form, dihydroartemisinin DHA, in the blood of infants receiving treatment, following World Health Organization recommendations for safety and relapse monitoring. Infants who are already part of the ARTEMUM study and receiving intravenous artesunate treatment will have up to four additional blood samples collected within the first 48 hours of treatment. These samples will be taken alongside standard care blood draws to measure artesunate and DHA concentrations. A further blood sample will be collected about one month after treatment for clinical laboratory tests. The collected plasma and red blood cells will be frozen for detailed analysis, including testing for specific mutations. Participants will be monitored during routine care, with blood samples timed to best capture drug levels shortly after dosing. Researchers will track changes in artesunate and DHA levels in plasma, as well as safety and tolerability by recording any adverse events and the number of doses given. Laboratory test results and clinical data will be gathered from the main ARTEMUM study forms. The total participation period includes initial treatment and follow-up approximately one month later.

Evaluation of Artesunate in Infants Being Treated for Severe Malaria