More data are urgently needed describing the pharmacology of drugs used to treat and prevent malaria in pregnant women.
The aim of this application is to plan a protocol that will study the safety, efficacy and pharmacokinetics in Zambian pregnant women of 2 combination drug products commonly used to treat and prevent malaria - Coartem (artemether-lumefantrine) and Fansidar (sulfadoxine-pyrimethamine). This protocol will be developed in collaboration with Zambian investigators and public health officials. The patient population for the protocol will be pregnant women in Zambia who have uncomplicated malaria. Women enrolling in the trial will receive one of the two study drug formulations, followed by serial blood sampling for anti-malaria drug concentrations and protein binding. Study subjects will be monitored for change in malaria symptoms and the blood malaria parasite load. Study mothers and their infants will also be monitored for any signs of toxicity from the drugs. This planning grant will be used to develop the detailed protocol needed for this clinical trial, to develop all the tools needed for subject enrollment and data collection, to obtain appropriate human studies approvals and to develop the necessary laboratory assays. The data from this planned study will provide the information needed to ensure that pregnant women receive the appropriate doses of these anti-malaria drugs. ? ? ?
