Tafenoquine and ACTs (TADORE- Plus)
TADORE+
1 other identifier
interventional
507
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2025
CompletedFirst Posted
Study publicly available on registry
July 11, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
March 18, 2026
June 1, 2025
2 years
July 2, 2025
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
incidence risk (time to first event) of any P. vivax parasitaemia
4 months
Study Arms (3)
Tafenoquine plus DHA-Piperaquine
EXPERIMENTALDHA-Piperaquine
NO INTERVENTIONTafenoquine plus artesunate-pyronaridine
EXPERIMENTALInterventions
Tafenoquine plus DHA-piperaquine
Tafenoquine plus Artesunate-pyronaridine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2025
First Posted
July 11, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
March 18, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
Submission to WWARN