Tafenoquine and DHA-piperaquine (TADORE- Plus)

NCT ID: NCT07060794

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Vivax Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tafenoquine plus DHA-Piperaquine

Group Type EXPERIMENTAL

Tafenoquine

Intervention Type DRUG

Tafenoquine in combination with DHA-piperaquine

DHA-Piperaquine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tafenoquine

Tafenoquine in combination with DHA-piperaquine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menzies School of Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Hellen Mnjala

Role: CONTACT

Other Identifiers

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TADORE+

Identifier Type: -

Identifier Source: org_study_id

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