Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Malaria is the most important human parasitic disease and is responsible of high morbidity
and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are
almost always excluded from clinical trials; thus, the investigators lack sufficient
information on the safety and efficacy of most antimalarials in pregnancy. The recommendation
of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and
3rd trimester is already implemented in several African countries, however documentation of
their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to
evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate,
mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women
with P. falciparum malaria; the results will help to recommend the optimal therapy for this
high-risk group in Africa.
Phase:
Phase 3
Details
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborators:
Centre Muraz Institute of Tropical Medicine(KIT), Amsterdam Kwame Nkrumah University of Science and Technology Liverpool School of Tropical Medicine National Institute for Medical Research, Tanzania Tropical Diseases Research Centre, Zambia University of Malawi College of Medicine