Tafenoquine and ACTs (TADORE- Plus)

ConditionVivax Malaria

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorMenzies School of Health Research

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

507 Participants

are divided into 3 treatment groups

Group A: Tafenoquine plus DHA-PiperaquineExperimental treatment 1 intervention

Group B: DHA-PiperaquineNo intervention 0 interventions

Group C: Tafenoquine plus artesunate-pyronaridineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

4 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Menzies School of Health Research

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: