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.