Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Comparing treatments for Plasmodium vivax malaria

Official title: Does Artemisinin Combination Treatment Reduce the Radical Curative Efficacy of High Dose Tafenoquine for Plasmodium Vivax Malaria?

Run by Shoklo Malaria Research Unit · NCT05788094 · Data updated 2026-11-12

This study is testing whether a new malaria treatment called tafenoquine works better when combined with other antimalarial drugs for people with Plasmodium vivax malaria.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment606 (estimated)
SponsorShoklo Malaria Research Unit
Academic / other
Locations1 site (Mae Sot, Changwat Tak)
StatusRecruiting
StartedJune 26, 2023
Main results expectedFebruary 28, 2026
Study endsAugust 31, 2026
Registry record updatedMay 16, 2025
Trial IDNCT05788094 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of P. vivax mono-infection and adequate G6PD enzyme activity.

Probably not a fit

Patients with concurrent P. falciparum malaria, severe anemia, or those who are pregnant or lactating will not benefit from this study.

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 evaluates the effectiveness of different treatment regimens for Plasmodium vivax malaria, focusing on the use of tafenoquine in combination with various antimalarial therapies. The study aims to determine whether artemisinin combination therapy (ACT) may interfere with the efficacy of tafenoquine, a single-dose medication that targets the liver stages of the malaria parasite. Participants will be monitored for four months to assess treatment outcomes and potential relapses. The trial is set in the Greater Mekong Subregion, an area significantly affected by this type of malaria.

Why it matters

Potential benefit: If successful, this study could provide a more effective and convenient treatment option for patients suffering from Plasmodium vivax malaria, potentially reducing relapse rates.

How similar studies have gone: Previous studies have indicated the potential effectiveness of tafenoquine, but this specific comparison with ACT is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with P. vivax mono-infection as diagnosed by Rapid Diagnostic Test
* Fever or history of fever in the previous 7 days
* Quantitative G6PD activity ≥70% of the population median i.e., ≥6.1U/gHb
* Age \> 18 years, Weight \>35 kg
* Ability to understand the study instructions and provide informed consent
* Willing to be followed for 4 months and likely to adhere to the study protocol.

Exclusion Criteria:

* Coincident P. falciparum malaria or other infections
* Pregnancy
* Lactation
* Hb \< 8 g/dL
* Quantitative G6PD activity \<70% of the population median i.e., \<6.1U/gHb
* Severe malaria (as per WHO guideline)
* History of allergic or haemolytic response to any of the study drugs

Where it's running

  • Shoklo Malaria Research Unit (SMRU)
    Mae Sot, Changwat Tak, Thailand
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.