Tafenoquine and DHA-piperaquine (TADORE- Plus) (TADORE+)

Menzies School of Health Research

Status and phase: Not yet enrolling; Phase 4

Conditions: Vivax Malaria

Treatments: Drug: Tafenoquine

Study type: Interventional

Funder types: Other

Identifiers

NCT07060794

TADORE+

Details and patient eligibility

About

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).

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Tafenoquine plus DHA-Piperaquine

Experimental group

Treatment:

Drug: Tafenoquine

DHA-Piperaquine

No Intervention group