Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine (EFFORT)

Menzies School of Health Research

Status and phase: Completed; Phase 3

Conditions: Vivax Malaria; Malaria Relapse; Malaria, Vivax; Plasmodium Vivax

Treatments: Drug: Tafenoquine; Drug: Primaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04411836

EFFORT

Details and patient eligibility

About

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

Full description

• 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

Enrollment: 960 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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960 participants in 3 patient groups

Control

No Intervention group

Description:

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

PQ Intervention

Experimental group

Description:

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

Treatment:

Drug: Primaquine

TQ Intervention

Experimental group

Description:

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

Treatment:

Drug: Tafenoquine