Overview

Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Oxford
Collaborators:
Indonesia-MoH
Mahidol University
Ministry of Health, Indonesia
Treatments:
Amodiaquine
Artemisinins
Artenimol
Artesunate
Dihydroartemisinin
Piperaquine
Primaquine
Criteria
Inclusion Criteria:

- Both sex

- Age > 1 year

- Fever (axillary temp ≥ 37.5oC) or history of fever during the preceding 48 hours

- Uncomplicated Plasmodium vivax confirm by microscopic examination

- Asexual parasite ≥ 250/µL blood

- Absence of clinical condition that need hospitalization

- No history of allergy to antimalarial drug

- Not consuming antibiotic with antimalarial activity

Exclusion Criteria:

- Clinical features of severe malaria

- Severe malnutrition

- Recurrent vomiting

- Concomitant infection

- Pregnant (test for β-HCG in women of child bearing age)

- Lactating mother

- Move out from study area

- Not eligible to follow up during study period