drugset / Trial / NCT03529396
Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients
Phase 2
Completed
106 enrolled
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collabOswaldo Cruz Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A clinical study to assess the safety and efficacy of alternative regimens of primaquine for radical cure of vivax malaria in glucose 6-phosphate dehydrogenase (G6PD) deficient. G6PD deficient patients with P. vivax monoinfection will be treated with either weekly or delayed one-week course of primaquine, and the currently recommended by national guideline, 12-week chloroquine regimen to compare treatment safety among groups. All groups will be actively monitored for hemolysis during treatment and will have six-month follow-up period to assess treatment efficacy.
Timeline
- Start
- 2018-07-20
- Primary completion
- 2022-12-20
- Completion
- 2023-07-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chloroquine | Small molecule | 5 mg/kg | — |
| Comparator | Primaquine | Small molecule | 0.5 mg/kg | — |
| Comparator | Primaquine | Small molecule | 0.75 mg/kg | — |