Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium
vivax malaria during November 2010 to March 2012. The aim of the study is to compare the
efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and
dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The
significance of the study is to find alternative drug for treating patients with vivax
malaria in case the standard treatment is not available or become resistance. This study will
give thorough information about the efficacy and safety of 2 artemisinin-based combination
therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry
of Health on their suggested policies for radical cure of vivax malaria, and provides
evidence based treatment options for chloroquine resistant vivax malaria. This study will
also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD)
deficiency and G6PD variants in North Sumatera population.
Phase:
Phase 3
Details
Lead Sponsor:
University of Oxford
Collaborators:
Indonesia-MoH Mahidol University Ministry of Health, Indonesia