Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
Malaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past
decades, P. falciparum has shown increasing resistance to chloroquine and
Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin
containing combination therapies (ACTs) are now the standard treatment of P. falciparum
malaria in areas with established resistance to traditional therapies. However, a standard
approach for using ACT in pregnancy does not exist in Africa, where some countries keep on
using quinine, while others allow the use of ACTs. Thus, there is need of establishing the
safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of
antimalarials may be altered during pregnancy and since available pharmacokinetic data are
still somewhat limited, we propose to carry out a study confirming or disproving existing
pharmacokinetic data (collected in South-East Asia), before starting any larger African
efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS),
developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which
will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women
in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched
non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborators:
Centre Muraz Liverpool School of Tropical Medicine