Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborators: Addis Ababa University; Ethiopian Public Health Institute; Mahidol Oxford Tropical Medicine Research Unit; National Centre for Parasitology, Entomology and Malaria Control, Cambodia; Universitas Sumatera Utara; University of Melbourne
• Treatments: Primaquine; Tafenoquine

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