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NCT Number: NCT06148792

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

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.

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Key information

Conditions

Vivax Malaria Infections Malaria Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr Marcus Lacerda, Manaus, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tafenoquine

Drug

oral treatment

Primaquine

Drug

oral treatment

Primary outcomes

  1. The incidence risk of vivax parasitaemia

    Time frame: 4 months

    The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy.

    • compared between TQRevised and the PQ7 (non-inferiority)
    • compared between TQRevised and TQStandard (superiority)

Secondary outcomes

  1. The incidence risk of vivax parasitaemia

    Time frame: 4 months

    The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy compared between TQStandard and PQ7

  2. The incidence risk of symptomatic vivax parasitaemia

    Time frame: 4 months

    The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy

  3. The incidence risk of vivax parasitaemia

    Time frame: 6 months

    The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy

  4. The incidence risk of symptomatic vivax parasitaemia

    Time frame: 6 months

    The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy

  5. The incidence rate of vivax parasitaemia

    Time frame: 6 months

    The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy

  6. The incidence rate of symptomatic vivax parasitaemia

    Time frame: 6 months

    The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy

  7. The incidence risk of anaemia

    Time frame: 7 and 14 days, 6 months

    The incidence risk of developing severe anaemia (Hb < 5g/dl) or moderate (5g/dl and <7g/dl) anaemia within 7 and 14 days of starting treatment and/or requiring blood transfusion within the 6 months follow up period

  8. The incidence risk of an acute drop in Hb

    Time frame: 7 and 14 days

    The incidence risk of an acute drop in Hb of >25% to <7g/dl within 7 and 14 days of starting treatment

  9. Adverse events

    Time frame: 42 days

    The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment

  10. Meth Hb concentration

    Time frame: day 7

    day 7 methaemoglobin concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Hellen Mnjala

CONTACT

[email protected]

+610889468675

kamala K Thriemer

CONTACT

[email protected]

+610889468644

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

  • Addis Ababa University
  • Arba Minch University
  • Curtin University
  • Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia
  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
  • Papua New Guinea Institute of Medical Research
  • University of Melbourne

Registry information

Official study title

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised

Acronym: TADORE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 28, 2023
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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