NCT07060794

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
507

participants targeted

Target at P75+ for phase_4

Timeline
24mo left

Started Jun 2026

Status
not yet recruiting

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 18, 2026

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

July 2, 2025

Last Update Submit

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

EXPERIMENTAL
Drug: Tafenoquine plus DHA-Piperaquine

DHA-Piperaquine

NO INTERVENTION

Tafenoquine plus artesunate-pyronaridine

EXPERIMENTAL
Drug: Tafenoquine plus Artesunate-pyronaridine

Interventions

Tafenoquine plus DHA-piperaquine

Tafenoquine plus DHA-Piperaquine

Tafenoquine plus Artesunate-pyronaridine

Tafenoquine plus artesunate-pyronaridine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Malaria, Vivax

Interventions

tafenoquinepyronaridine tetraphosphate, artesunate drug combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

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