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Not yet recruiting NCT07060794

Tafenoquine and ACTs (TADORE- Plus)

Phase IV Interventional Vivax Malaria

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tafenoquine plus DHA-Piperaquine, Tafenoquine plus Artesunate-pyronaridine.
Who it may be relevant to
Registry conditions: Vivax Malaria. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Drug Tafenoquine plus DHA-Piperaquine
    Tafenoquine plus DHA-piperaquine
  • Drug Tafenoquine plus Artesunate-pyronaridine
    Tafenoquine plus Artesunate-pyronaridine

Primary outcome measures

  • incidence risk (time to first event) of any P. vivax parasitaemia [Time frame: 4 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07060794 · TADORE+

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗