A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Last updated: July 15, 2025
Sponsor: Menzies School of Health Research
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Tafenoquine

Primaquin

Primaquine

Clinical Study ID

NCT06148792
TADORE
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • P. vivax peripheral parasitaemia (mono-infection)

  • G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined bythe 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

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 Design

Total Participants: 1090
Treatment Group(s): 3
Primary Treatment: Tafenoquine
Phase: 3
Study Start date:
May 10, 2024
Estimated Completion Date:
March 01, 2027

Connect with a study center

  • Dr Marcus Lacerda

    Manaus,
    Brazil

    Active - Recruiting

  • Arba Minch General Hospital

    Arba Minch,
    Ethiopia

    Active - Recruiting

  • Puskesmas Hanura

    Hanura,
    Indonesia

    Site Not Available

  • Dr Rini Poespoprodjo

    Timika,
    Indonesia

    Site Not Available

  • Dr Moses Laman and Dr Brioni Moore

    Alexishafen,
    Papua New Guinea

    Active - Recruiting

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