Status:
RECRUITING
Southeast Asia Dose Optimization of Tafenoquine
Lead Sponsor:
University of Oxford
Conditions:
Plasmodium Vivax Malaria
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief 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 P...
Detailed Description
Study design A total of 700 participants will be enrolled and randomized to one of two arms: the currently recommended tafenoquine dose (TQ-current; e.g., 300mg adult dose) or a 50% higher tafenoquin...
Eligibility Criteria
Inclusion
- Patients with symptomatic P. vivax mono-infection as diagnosed by microscopy
- Fever or history of fever in the previous 7 days
- Quantitative G6PD activity ≥70% of the population median
- Weight \>10 kg and ≥2 years old
- Ability to understand the study instructions and provide written informed consent.
- Willing to be followed for 4 months
Exclusion
- Pregnancy
- Lactation
- Hb \< 8 g/dL
- Severe malaria
- Blood transfusion in the last 4 months
- History of allergic response to an 8-aminoquinoline or the nationally recommended schizonticide (e.g., chloroquine, artemether-lumefantrine)
- Any previous history of a haemolytic event Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study (e.g. chronic disease, medications that potentiate or inhibit CYP2D6 or CYP2C8 isoenzyme function)
Key Trial Info
Start Date :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 7 2028
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT04704999
Start Date
July 22 2024
End Date
February 7 2028
Last Update
March 6 2025
Active Locations (5)
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1
Mahidol Oxford Tropical Medicine Research Unit (MORU), Cambodia
Siem Reap, Cambodia
2
Lao Oxford Mahosot Hospital Wellcome Trust Research Unit (LOMWRU)
Vientiane, Laos
3
Mahidol Vivax Research Unit (MVRU)
Bangkok, Thailand
4
Shoklo Malaria Research Unit (SMRU)
Bangkok, Thailand