Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients

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

• 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

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