drugset / Trial / NCT02174900
Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)
Phase 2/3
Completed
70 enrolled
London School of Hygiene and Tropical Medicine
Centre national de recherche et de formation sur le paludisme · collabUniversity Medical Center Nijmegen · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Primaquine | Small molecule | 0.25 mg/kg | — |
| Subject | Primaquine | Small molecule | 0.4 mg/kg | — |
| Comparator | Artemether-lumefantrine | Unknown | — | — |