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A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Recruiting
18 years and older
All
Phase 3

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Overview

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.

Eligibility

Inclusion Criteria:

  • P. vivax peripheral parasitaemia (mono-infection)
  • G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
  • Fever (temperature ≥37.5⁰C) 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

Exclusion Criteria:

  • 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.

Study details
    Vivax Malaria

NCT06148792

Menzies School of Health Research

30 April 2025

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