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

NCT03529396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

  • Vivax Malaria
  • G6PD Deficiency

Interventions

DRUG

Chloroquine

Standard chloroquine (three days)

DRUG

Primaquine

Daily Primaquine (0.5 mg of base/kg/day for seven days) starting only at the fifth day post chloroquine initiation.

DRUG

Primaquine

Weekly primaquine (0.75 mg of base/kg/week for eight weeks) starting with first dose of chloroquine.

DRUG

Chloroquine

Weekly, once a week chloroquine (5 mg of base/kg/week for twelve weeks)

DRUG

Primaquine

Standard primaquine (0.5mg of base/kg/day for seven days) concomitant with chloroquine.

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

    lead OTHER

Principal Investigators

  • Marcus VG Lacerda, MD, PhD · Fiocruz/ILMD and Fundacao de Medicina Tropical Dr Heitor Vieira Dourado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-20
Primary Completion
2022-12-20
Completion
2023-07-06

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529396 on ClinicalTrials.gov