Tafenoquine and DHA-piperaquine (TADORE- Plus)

Not Applicable

Not yet recruiting

• Conditions: Vivax Malaria
• Interventions: Drug: Tafenoquine

• Registration Number: NCT07060794
• Lead Sponsor: Menzies School of Health Research

Brief Summary

A trial designed to determine whether there is a clinically significant drug-drug interaction of tafenoquine with DHA-piperaquine using a control arm with radical cure given at the end of follow up (delayed radical cure).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-11-01
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tafenoquine plus DHA-Piperaquine	Tafenoquine	-

Primary Outcome Measures

Name	Time	Method
incidence risk (time to first event) of any P. vivax parasitaemia	4 months