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Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

NCT07468513 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-12

No results posted yet for this study

Summary

A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg/kg per day over 7 days) among patients with intermediate (30-70%) G6PD activity and the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\<30% activity)

Conditions

  • Vivax Malaria
  • G6PD Deficiency

Interventions

DRUG

Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days

Primaquine 1mg/kg/day for 7 days

DRUG

Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).

8 weekly Primaquine (0.75mg/kg dose).

Sponsors & Collaborators

  • Curtin University

    collaborator OTHER

  • University of Melbourne

    collaborator OTHER

  • Arba Minch University

    collaborator OTHER

  • Papua New Guinea Institute of Medical Research

    collaborator OTHER_GOV

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    collaborator OTHER

  • Indonesia University

    collaborator OTHER

  • Menzies School of Health Research

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • Brazil
  • Ethiopia
  • Papua New Guinea

Study Locations

More Related Trials

Entities

Companies

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 NCT07468513 on ClinicalTrials.gov