Tafenoquine and ACTs (TADORE- Plus) (TADORE+)

March 16, 2026 updated by: Menzies School of Health Research
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

507

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Haemoglobin at presentation ≥8g/dl
  • 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
  • Pregnant or lactating females
  • Regular use of drugs with haemolytic potential
  • Known hypersensitivity to any of the study drugs
  • History of any psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tafenoquine plus DHA-Piperaquine
Drug: Tafenoquine plus DHA-Piperaquine
Tafenoquine plus DHA-piperaquine
No Intervention: DHA-Piperaquine
Experimental: Tafenoquine plus artesunate-pyronaridine
Drug: Tafenoquine plus Artesunate-pyronaridine
Tafenoquine plus Artesunate-pyronaridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence risk (time to first event) of any P. vivax parasitaemia
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menzies School of Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 2, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TADORE+

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Submission to WWARN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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