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

RecruitingPhase 4Ages 18 Years - anyAllShoklo Malaria Research Unit
NCT05788094 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020 ASTMH Annual Meeting) . This could

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📋 Eligibility rules (as published)
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
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What it tests

  • Dihydroartemisinin-piperaquine plus tafenoquine (450 mg adult dose)
  • Chloroquine plus Tafenoquine (450 mg adult dose)
  • Artemether-Lumefantrine plus Tafenoquine (450 mg adult dose)
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Where

1 site
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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