Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06148792

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Led by Menzies School of Health Research · Updated on 2025-07-18

1090

Participants Needed

4

Research Sites

146 weeks

Total Duration

On this page

Sponsors

M

Menzies School of Health Research

Lead Sponsor

U

University of Melbourne

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • P. vivax peripheral parasitaemia (mono-infection)
  • G6PD normal status (G6PD activity 970% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
  • Fever (temperature 937.5�B0C) or history of fever in the preceding 48 hours
  • Written informed consent
  • Living in the study area and willing to be followed for six months
Not Eligible

You will not qualify if you...

  • Danger signs or symptoms of severe malaria
  • Anaemia (defined as Hb <8g/dl)
  • Pregnant or lactating females
  • Regular use of drugs with haemolytic potential
  • Known hypersensitivity to any of the study drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Dr Marcus Lacerda

Manaus, Brazil

Actively Recruiting

2

Arba Minch General Hospital

Arba Minch, Ethiopia

Actively Recruiting

3

Puskesmas Hanura

Hanura, Indonesia

Not Yet Recruiting

4

Dr Moses Laman and Dr Brioni Moore

Alexishafen, Papua New Guinea

Actively Recruiting

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Research Team

H

Hellen Mnjala

CONTACT

K

kamala K Thriemer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria | DecenTrialz