Optimizing Tafenoquine Dosing for Malaria Treatment in Southeast Asia
Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia
PHASE4 · University of Oxford · NCT04704999
This study is testing whether a higher dose of tafenoquine can work better than the standard dose for treating malaria in Southeast Asia.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | University of Oxford (other) |
| Locations | 5 sites (Siem Reap and 4 other locations) |
| Trial ID | NCT04704999 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal dose of tafenoquine, a medication for treating Plasmodium vivax malaria, in Southeast Asia. A total of 700 participants will be randomized into two groups: one receiving the currently recommended dose of 300 mg and the other receiving a higher dose of 450 mg. Participants will be monitored closely for efficacy and safety, with follow-ups extending for four months. The study employs a double-blind design to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 years and older with symptomatic P. vivax malaria and adequate G6PD enzyme activity.
Not a fit: Patients who are pregnant, lactating, or have severe malaria or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective single-dose treatment for Plasmodium vivax malaria, improving patient outcomes.
How similar studies have performed: Other studies have shown varying success with tafenoquine, but this specific dose optimization approach is novel and untested in this region.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Siem Reap and 4 other locations
- Mahidol Oxford Tropical Medicine Research Unit (MORU), Cambodia — Siem Reap, Cambodia (NOT_YET_RECRUITING)
- Lao Oxford Mahosot Hospital Wellcome Trust Research Unit (LOMWRU) — Vientiane, Laos (RECRUITING)
- Mahidol Vivax Research Unit (MVRU) — Bangkok, Thailand (NOT_YET_RECRUITING)
- Shoklo Malaria Research Unit (SMRU) — Bangkok, Thailand (NOT_YET_RECRUITING)
- Oxford University Clinical Research Unit (OUCRU) — Bình Phước, Vietnam (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Cindy Chu, MD, PhD — Lao-Oxford-Mahosot Hospital-Wellcome Research Unit
- Study coordinator: Cindy Chu, MD, PhD
- Email: cindy@tropmedres.ac
- Phone: +856 (0) 21 250 752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Plasmodium Vivax Malaria, Plasmodium vivax, Relapse, 8-aminoquinoline, Tafenoquine, Radical cure, Drug efficacy, Adults