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Search / Trial NCT05788094

ACT vs CQ With Tafenoquine for P. Vivax Mono-infection

Launched by SHOKLO MALARIA RESEARCH UNIT · Mar 15, 2023

Trial Information

Current as of September 07, 2025

Recruiting

Keywords

Artemisinin Combination Treatment Tafenoquine Plasmodium Vivax Malaria Malaria

ClinConnect Summary

This clinical trial is studying a new treatment for P. vivax malaria, a common type of malaria that can hide in the liver and cause repeated illness. Researchers want to see if a higher dose of a medication called tafenoquine (450 mg) can work well when taken with another treatment known as Artemisinin Combination Therapy (ACT). The goal is to find a more effective and convenient way to treat this malaria, especially since the current treatments can take a long time and may not work as well in some cases.

To be eligible for the trial, participants must be at least 18 years old, weigh more than 35 kg, and have been diagnosed with P. vivax malaria. They should also have had a fever recently and meet certain health criteria related to a specific blood enzyme. Participants will need to be willing to follow the study guidelines for about four months. In this trial, individuals can expect to receive close monitoring of their health and the chance to contribute to research that may improve malaria treatment options in the future.

Gender

ALL

Eligibility 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

About Shoklo Malaria Research Unit

The Shoklo Malaria Research Unit (SMRU) is a prominent clinical research organization dedicated to advancing the understanding and treatment of malaria and other infectious diseases in Southeast Asia. Based in Thailand, SMRU conducts innovative research that integrates epidemiology, clinical trials, and laboratory studies to develop effective interventions and improve health outcomes for vulnerable populations. With a strong commitment to ethical research practices and community engagement, SMRU collaborates with international partners to address the challenges posed by malaria and contribute to global health initiatives. Its expertise and contributions are vital in the ongoing fight against malaria, particularly in areas with high transmission rates.

Locations

Mae Sot, Tak, Thailand

Patients applied

0 patients applied

Trial Officials

Francois Nosten, Prof

Principal Investigator

Shoklo Malaria Research Unit

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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