Comparison of the Efficacy and Safety of Two ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria in North Sumatera, Indonesia: 1 Year Followup (ACTPQ)

NCT01288820 Phase 3 COMPLETED

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.

Details

Lead sponsor	University of Oxford
Phase	Phase 3
Status	COMPLETED
Enrolment	331
Start date	2011-01
Completion	2012-04

Conditions

• Vivax Malaria

Interventions

• Dihydroartemisinin/piperaquine + primaquine
• Artesunate-amodiaquine + primaquine

Primary outcomes

• Assessment of cure rate of both arms AS-AQ + PQ and DHP+PQ — 42 days
  Evaluate the relative efficacy of the study drugs in providing parasite clearance over the observation period of 42 days.

Countries

Indonesia