Vivax Malaria Clinical Trial
— ACTPQOfficial title:
Comparison of the Efficacy and Safety of Two ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria in North Sumatera, Indonesia: 1 Year Followup
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.
Status | Completed |
Enrollment | 331 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year and older |
Eligibility |
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 ß-HCG in women of child bearing age) - Lactating mother - Move out from study area - Not eligible to follow up during study period |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Labuhan Batu Utara Regency Tanjung leidong village | North Sumatra | North Sumatera |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Mahidol University, Ministry of Health, Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of cure rate of both arms AS-AQ + PQ and DHP+PQ | Evaluate the relative efficacy of the study drugs in providing parasite clearance over the observation period of 42 days. | 42 days | No |
Secondary | To assess the effects of drugs on parasite clearance and malaria associated symptoms | Effect of drug trial on subsequent relapse of Plasmodium vivax. Gametocyte carriage rates. Gametocyte clearance time. Proportion of subjects with fever, parasitemia clearance and increase methemoglobin level. Hematological recovery. Proportion of subjects with hemolysis. |
42 days | No |
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