A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Launched by MENZIES SCHOOL OF HEALTH RESEARCH · Nov 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat vivax malaria, a type of malaria caused by the Plasmodium vivax parasite. Researchers want to see if a revised dose of a medication called tafenoquine, based on a patient’s weight, is as effective and safe as a higher dose of another malaria treatment called primaquine. Specifically, they are testing a tafenoquine dose of 7.5 mg/kg and comparing it to a fixed dose of 300 mg and the higher dose of primaquine (7 mg/kg). The trial will also look at how well patients tolerate the new dosing method and whether it's easy for them to take.

To join this trial, participants need to be diagnosed with vivax malaria and have normal G6PD enzyme activity, which is important for safely taking tafenoquine. They should also have had a fever recently or are currently experiencing one. Participants must be willing to provide consent and stay in the study for six months. However, those with severe malaria symptoms, anemia, pregnancy, or certain other health conditions cannot participate. If someone joins the study, they will receive the tafenoquine treatment and have regular follow-ups to monitor their health and response to the medication. This trial is currently recruiting participants of all genders, aged 65 to 74.

Gender

ALL

Eligibility criteria

• 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 (SDBioline, ROK))
• • Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
• • 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
• • Regular use of drugs with haemolytic potential
• • Known hypersensitivity to any of the study drugs.