Actively Recruiting
ACT vs CQ With Tafenoquine for P. Vivax Mono-infection
Led by Shoklo Malaria Research Unit · Updated on 2025-05-16
606
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
Sponsors
S
Shoklo Malaria Research Unit
Lead Sponsor
M
Mahidol Oxford Tropical Medicine Research Unit
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019 NEJM; Watson et al. 2022a Elife). A tafenoquine dose of 450mg is predicted to provide \>90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.
CONDITIONS
Official Title
ACT vs CQ With Tafenoquine for P. Vivax Mono-infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6570% of the population median (at least 6.1 U/gHb)
- Age over 18 years and weight over 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
You will not qualify if you...
- Coincident P. falciparum malaria or other infections
- Pregnancy
- Lactation
- Hemoglobin less than 8 g/dL
- Quantitative G6PD activity below 70% of the population median (less than 6.1 U/gHb)
- Severe malaria as per WHO guideline
- History of allergic or hemolytic response to any of the study drugs
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, Thailand, 63110
Actively Recruiting
Research Team
A
Aung Pyae Phyo, DPhil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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