Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria
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.
Timeline
- Start
- 2011-01
- Primary completion
- 2012-04
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 2.25 mg/kg | Oral |
| Comparator | Artesunate | Small molecule | 4 mg/kg | Oral |
| Comparator | amodiaquine | Other / unclassified | 10 mg/kg | Oral |
| Subject | piperaquine | Small molecule | 16 mg/kg | Oral |
| Subject | piperaquine | Small molecule | 18 mg/kg | Oral |
| Background | Primaquine | Small molecule | 15 mg/kg | Oral |