NCT05788094 ACT vs CQ With Tafenoquine for P. Vivax Mono-infection
| NCT ID | NCT05788094 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shoklo Malaria Research Unit |
| Condition | Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 606 participants |
| Start Date | 2023-06-26 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 606 participants in total. It began in 2023-06-26 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Francois Nosten, Prof
PRINCIPAL INVESTIGATOR
Shoklo Malaria Research Unit
Frequently Asked Questions
Who can join the NCT05788094 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05788094 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05788094 currently recruiting?
Yes, NCT05788094 is actively recruiting participants. Contact the research team at aungpyaephyo@tropmedres.ac for enrollment information.
Where is the NCT05788094 trial being conducted?
This trial is being conducted at Mae Sot, Thailand.
Who is sponsoring the NCT05788094 clinical trial?
NCT05788094 is sponsored by Shoklo Malaria Research Unit. The principal investigator is Francois Nosten, Prof at Shoklo Malaria Research Unit. The trial plans to enroll 606 participants.