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Not yet recruitingNCT07060794TADORE+Updated Mar 18, 2026

Tafenoquine and ACTs (TADORE- Plus)

A Phase 4 interventional study of Tafenoquine plus DHA-Piperaquine and Tafenoquine plus Artesunate-pyronaridine in Vivax Malaria, sponsored by Menzies School of Health Research. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Menzies School of Health Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
507
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

A trial designed to determine whether there is a clinically significant drug-drug interaction of tafenoquine with DHA-piperaquine or artesunate-pyronaridine using a control arm with radical cure given at the end of follow up (delayed radical cure).

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Conditions studied

  • Vivax Malaria

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03

In context

Malaria, Vivax

123 studies on the registry are indexed under Malaria, Vivax; 19 are open to participants now.

This study's planned enrollment of 507 is above the median of 150 across 103 interventional studies indexed under Malaria, Vivax.

Browse Malaria, Vivax studies →

Lead sponsor

Menzies School of Health Research is the lead sponsor of 45 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (SD Biosensor, ROK))
  • Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
  • Age ≥18 years
  • at presentation ≥8g/dl
  • Written .
  • Living in the study area and willing to be followed for six months

Exclusion criteria

Exclusion Criteria:

  • Danger signs or symptoms of severe malaria
  • Pregnant or lactating females
  • Regular use of drugs with haemolytic potential
  • Known to any of the study drugs
  • History of any psychiatric disorder
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
507 participants (estimated)

Study arms

  • Experimental
    Tafenoquine plus DHA-Piperaquine

    Drug: Tafenoquine plus DHA-Piperaquine

  • No intervention
    DHA-Piperaquine
  • Experimental
    Tafenoquine plus artesunate-pyronaridine

    Drug: Tafenoquine plus Artesunate-pyronaridine

Interventions

  • DrugTafenoquine plus DHA-Piperaquine

    Tafenoquine plus DHA-piperaquine

  • DrugTafenoquine plus Artesunate-pyronaridine

    Drug page: Tafenoquine

    Tafenoquine plus Artesunate-pyronaridine

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What researchers measure

Primary outcomes

  1. incidence risk (time to first event) of any P. vivax parasitaemia

    Time frame: 4 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — Submission to WWARN

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07060794
Lead sponsor
Menzies School of Health Research
Responsible party
Sponsor
First posted
Jul 11, 2025
Start date
Jun 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Mar 18, 2026

Study contacts

Hellen Mnjala
Contact
hellen.mnjala@menzies.edu.au
000

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tafenoquine

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