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A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

NCT06148792 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1090

Last updated 2025-07-18

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\[s\] it aims to answer are:

* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days)
* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg)
* is the tolerability and safety of TQRevised acceptable
* is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.

Conditions

  • Vivax Malaria

Interventions

DRUG

Tafenoquine

oral treatment

DRUG

Primaquine

oral treatment

Sponsors & Collaborators

  • University of Melbourne

    collaborator OTHER

  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

    collaborator OTHER

  • Arba Minch University

    collaborator OTHER

  • Addis Ababa University

    collaborator OTHER

  • Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia

    collaborator UNKNOWN

  • Curtin University

    collaborator OTHER

  • Papua New Guinea Institute of Medical Research

    collaborator OTHER_GOV

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • Kamala N Thriemer, PhD · Menzies School of Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2027-03-01
Completion
2027-03-01

Countries

  • Brazil
  • Ethiopia
  • Indonesia
  • 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 NCT06148792 on ClinicalTrials.gov