Overview

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

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Oswaldo Cruz Foundation
Treatments:
Chloroquine
Chloroquine diphosphate
Primaquine
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.