drugset / Trial / NCT03529396

Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients

NCT03529396

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

EvaluationDrugModalityDoseRoute
Comparator Chloroquine Small molecule 5 mg/kg
Comparator Primaquine Small molecule 0.5 mg/kg
Comparator Primaquine Small molecule 0.75 mg/kg