Malaria
Conditions
Brief summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
Interventions
DRUGdihydroartemisinin-piperaquine
DRUG0.125 mg/kg Primaquine
DRUG0.5 mg/kg Primaquine
DRUG0.0625 mg/kg Primaquine
Sponsors
Malaria Research and Training Center, Bamako, Mali
Shoklo Malaria Research Unit
Mahidol Oxford Tropical Medicine Research Unit
Bill and Melinda Gates Foundation
Wellcome Trust
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * Age \>= 18 years and \< 50 years * Malaria blood thick film positive * Presence of gametocytes on thick blood film * Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits * No allergies to study drugs * Hemoglobin \>= 8 g/dl * No evidence of severe or chronic disease * Written, informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mosquito infectivity assessed through membrane feeding | 7 days | Baseline, Days 1, 2, 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gametocyte prevalence and density | 28 days | Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28 |
| primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite | 24 hours | Hours 1, 2, 3, 4, 6, 8, 12, 24 |
| asexual parasite prevalence and density | 28 days | Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28 |
| safety measurements including hemoglobin and signs of hemolysis | 28 days | Baseline, Days 1, 2, 3, 7, 14, 28 |
Countries
Mali
Outcome results
None listed