Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients
Vivax Malaria, G6PD Deficiency
About this trial
This is an interventional treatment trial for Vivax Malaria focused on measuring G6PD deficiency, Acute hemolytic anemia, Vivax malaria, Primaquine, Weekly primaquine, Chloroquine, Weekly chloroquine, Brazilian Amazon, Oxidative stress
Eligibility Criteria
Inclusion Criteria:
- Uncomplicated vivax malaria monoinfection
- G6PD deficiency ranging from 10%-60% of adjusted mean male activity
- Baseline hemoglobin >9 g/dL
- Willing to comply with study requirements
Exclusion Criteria:
- Pregnancy or breastfeeding
- Comorbidities (hepatopathy and/or nephropathy)
- Use of antimalarials in the previous two weeks or current use of potentially hemolytic drugs
- Any condition which would place the subject at undue risk of hemolysis or interfere with the results of the study, as judged by investigator.
Sites / Locations
- Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
- Centro de Pesquisa em Medicina Tropical (Cepem)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
1a: Chloroquine + 5th-day Primaquine
1b: Chloroquine + 8-week Primaquine
1c: Chloroquine + 12-week Chloroquine
2: Standard chloroquine + primaquine
[ARM HALTED PREMATURELY DUE TO SAFETY CONCERNS]
26 G6PD deficient patients. Directly observed therapy.
26 G6PD deficient patients. Control group in terms of safety. Directly observed therapy.
52 G6PD normal patients. Control group in terms of efficacy. Directly observed therapy.