RecruitingPhase 4NCT04704999

Southeast Asia Dose Optimization of Tafenoquine

Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia


Sponsor

University of Oxford

Enrollment

700 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg/kg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg/kg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Artemether 20 mg-Lumefantrine 120 mg, a drug called Chloroquine, and others for people with plasmodium vivax malaria. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 2 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTafenoquine

Tafenoquine will be given as 100mg coated tablets. Tablets will be given based on weight bands.

DRUGChloroquine

Chloroquine will be given as daily dose over 3 days (25mg/kg total dose divided 10/10/5mg/kg)

DRUGArtemether 20 mg-Lumefantrine 120 mg

Artemether-lumefantrine will be given twice daily over 3 days. Whole tablets will be given based on weight bands.


Locations(5)

Mahidol Oxford Tropical Medicine Research Unit (MORU), Cambodia

Siem Reap, Cambodia

Lao Oxford Mahosot Hospital Wellcome Trust Research Unit (LOMWRU)

Vientiane, Laos

Mahidol Vivax Research Unit (MVRU)

Bangkok, Thailand

Shoklo Malaria Research Unit (SMRU)

Bangkok, Thailand

Oxford University Clinical Research Unit (OUCRU)

Bình Phước, Vietnam

View Full Details on ClinicalTrials.gov

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NCT04704999


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