Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-25

Study Completion Date

2024-09-30

Brief Summary

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Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

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Detailed Description

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* To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days).
* To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen.
* To assess the safety of tafenoquine compared to the high and low dose primaquine regimens.
* To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

Conditions

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Vivax Malaria Plasmodium Vivax Malaria, Vivax Malaria Relapse

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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Control

Patients are treated with schizontocidal treatment plus low dose PQ (total dose 3.5mg/kg) unsupervised over 14 days (PQ14)

Group Type NO_INTERVENTION

No interventions assigned to this group

PQ Intervention

Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Group Type EXPERIMENTAL

Primaquine

Intervention Type DRUG

patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

TQ Intervention

Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ)

Group Type EXPERIMENTAL

Tafenoquine

Intervention Type DRUG

patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).

Interventions

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Tafenoquine

patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).

Intervention Type DRUG

Primaquine

patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Intervention Type DRUG

Other Intervention Names

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Primaquine 7 days

Eligibility Criteria

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Inclusion Criteria

* P. vivax peripheral parasitaemia (mono-infection) as determined by microscopy
* G6PD normal status (G6PD activity ≥ 70% of the adjusted male median as determined by the Biosensor™ (SD Biosensor, ROK))
* Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
* Age ≥18 years
* 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
* Anaemia (defined as Hb \<8g/dl)
* Pregnant or lactating females
* Known hypersensitivity to any of the study drugs
* Regular use of drugs with haemolytic potential

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No