Vivax MalariaPhase 4TADORE+NCT07060794
Tafenoquine and ACTs (TADORE- Plus)
A Phase 4 study testing Tafenoquine plus DHA-Piperaquine and Tafenoquine plus Artesunate-pyronaridine in people with Vivax Malaria, run by Menzies School of Health Research.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vivax Malaria
- What is being tested?
- Tafenoquine plus DHA-Piperaquine and Tafenoquine plus Artesunate-pyronaridine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
- Conditions
- Vivax Malaria
- Being tested
- Tafenoquine plus DHA-Piperaquine, Tafenoquine plus Artesunate-pyronaridine
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafenoquine plus DHA-PiperaquineDrug
Tafenoquine plus DHA-piperaquine
Tafenoquine plus Artesunate-pyronaridineDrug
Tafenoquine plus Artesunate-pyronaridine
| Study group | Role | What they receive |
|---|---|---|
| Tafenoquine plus DHA-Piperaquine | Experimental | Not described Receives: Drug: Tafenoquine plus DHA-Piperaquine |
| DHA-Piperaquine | No intervention | Not described |
| Tafenoquine plus artesunate-pyronaridine | Experimental | Not described Receives: Drug: Tafenoquine plus Artesunate-pyronaridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence risk (time to first event) of any P. vivax parasitaemia
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vivax MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 507 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060794
- Sponsor's protocol ID
- TADORE+
- Acronym
- TADORE+
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Submission to WWARN
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tafenoquine and ACTs (TADORE- Plus)
- ClinicalTrials.gov ID
- NCT07060794
- Acronym / sponsor ID
- TADORE+ / TADORE+
- Conditions
- Vivax Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 507 participants (estimated)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tafenoquine plus DHA-Piperaquine | Experimental | Drug: Tafenoquine plus DHA-Piperaquine |
| DHA-Piperaquine | No intervention | – |
| Tafenoquine plus artesunate-pyronaridine | Experimental | Drug: Tafenoquine plus Artesunate-pyronaridine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tafenoquine plus DHA-PiperaquineTafenoquine plus DHA-piperaquine | Drug | Tafenoquine plus DHA-Piperaquine |
| Tafenoquine plus Artesunate-pyronaridineTafenoquine plus Artesunate-pyronaridine | Drug | Tafenoquine plus artesunate-pyronaridine |
Primary outcome
incidence risk (time to first event) of any P. vivax parasitaemia
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Yes. Submission to WWARN
Related trials for Vivax Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Malaria
Not yet recruitingPhase 1
Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
Malaria Vaccine
Not yet recruitingPhase 2
This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria
Malaria, Malaria Vivax
RecruitingPhase 4
Southeast Asia Dose Optimization of Tafenoquine
Plasmodium Vivax Malaria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tafenoquine plus DHA-Piperaquine and Tafenoquine plus Artesunate-pyronaridine in people with Vivax Malaria, run by Menzies School of Health Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hellen Mnjala (000, hellen.mnjala@menzies.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence risk (time to first event) of any P. vivax parasitaemia (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.