Actively Recruiting
Southeast Asia Dose Optimization of Tafenoquine
Led by University of Oxford · Updated on 2025-03-06
700
Participants Needed
5
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Southeast Asia Dose Optimization of Tafenoquine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic Plasmodium vivax mono-infection confirmed by microscopy
- Fever or history of fever within the past 7 days
- Glucose-6-phosphate dehydrogenase (G6PD) activity of at least 70% of the population median
- Weight over 10 kg and age 2 years or older
- Ability to understand study instructions and provide written informed consent
- Willingness to be followed for 4 months
You will not qualify if you...
- Pregnancy
- Breastfeeding
- Hemoglobin less than 8 g/dL
- Severe malaria
- Blood transfusion within the last 4 months
- History of allergic reaction to 8-aminoquinoline drugs or nationally recommended schizonticidal agents (e.g., chloroquine, artemether-lumefantrine)
- Any previous history of hemolytic events
- Any condition that the investigator believes poses undue risk or could interfere with study results (e.g., chronic disease, medications affecting CYP2D6 or CYP2C8 enzyme function)
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Trial Site Locations
Total: 5 locations
1
Mahidol Oxford Tropical Medicine Research Unit (MORU), Cambodia
Siem Reap, Cambodia
Not Yet Recruiting
2
Lao Oxford Mahosot Hospital Wellcome Trust Research Unit (LOMWRU)
Vientiane, Laos
Actively Recruiting
3
Mahidol Vivax Research Unit (MVRU)
Bangkok, Thailand
Not Yet Recruiting
4
Shoklo Malaria Research Unit (SMRU)
Bangkok, Thailand
Not Yet Recruiting
5
Oxford University Clinical Research Unit (OUCRU)
Bình Phước, Vietnam
Not Yet Recruiting
Research Team
C
Cindy Chu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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