Tafenoquine and ACTs (TADORE- Plus) | NCT07060794

Studies
Tafenoquine and ACTs (TADORE- Plus)

NCT07060794

Sponsor

Menzies School of Health Research

Status

Not yet recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

507Estimated

Phase

Phase 4

Conditions

Vivax Malaria

Interventions

Tafenoquine plus DHA-Piperaquine
Tafenoquine plus Artesunate-pyronaridine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Jun 2028Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Jul 2, 2025

First Submission Date that Met QC Criteria

Jul 2, 2025

First Posted Date

Jul 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

507Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tafenoquine plus DHA-Piperaquine	Drug	Tafenoquine plus DHA-piperaquine	Tafenoquine plus DHA-Piperaquine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hellen Mnjala	Contact	000		hellen.mnjala@menzies.edu.au

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Submission to WWARN

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016780	Malaria, Vivax

Ancestor Terms

ID	Term
D008288	Malaria
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C055852	tafenoquine
C000712628	pyronaridine tetraphosphate, artesunate drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided