Optimizing Tafenoquine Dosing for Malaria Treatment in Southeast Asia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mahidol Oxford Tropical Medicine Research Unit (MORU), Cambodia
  Siem Reap, Cambodia Recruiting
• Lao Oxford Mahosot Hospital Wellcome Trust Research Unit (LOMWRU)
  Vientiane, Laos Recruiting
• Mahidol Vivax Research Unit (MVRU)
  Bangkok, Thailand Recruiting
• Shoklo Malaria Research Unit (SMRU)
  Bangkok, Thailand Recruiting
• Oxford University Clinical Research Unit (OUCRU-Indonesia)
  Jayapura, Indonesia 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inoculation of infected blood cells to study Plasmodium vivax malaria

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• Serology-guided radical treatment to reduce Plasmodium vivax relapses in Ethiopia and Madagascar

  This project will use an antibody blood test to find people recently infected with P. vivax and give G6PD-tested patients primaquine plus a blood-stage antimalarial to try to prevent relapses in selected communities.

  Recruiting Phase 3 London School of Hygiene and Tropical Medicine · Addis Ababa and 1 other locations · NCT06923592

• Comparing Tafenoquine and Primaquine for treating P. Vivax Malaria in India

  This study is testing whether Tafenoquine combined with Chloroquine works better and is safer than Primaquine with Chloroquine for treating P. Vivax malaria in people aged 2 and older in India.

  Recruiting at 5 sites Phase 3 GlaxoSmithKline · Ahmedabad and 4 other locations · NCT06666491

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.