Tafenoquine and ACTs (TADORE- Plus)

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).

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Key information

Conditions

Vivax Malaria Infections Malaria Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tafenoquine plus DHA-Piperaquine

Drug

Tafenoquine plus DHA-piperaquine

Tafenoquine plus Artesunate-pyronaridine

Drug

Tafenoquine plus Artesunate-pyronaridine

Primary outcomes

incidence risk (time to first event) of any P. vivax parasitaemia

Time frame: 4 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hellen Mnjala

CONTACT

[email protected]

000

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Registry information

Acronym: TADORE+

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jul 11, 2025
Registry last updated: Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed