Comparing treatments for Plasmodium vivax malaria
Does Artemisinin Combination Treatment Reduce the Radical Curative Efficacy of High Dose Tafenoquine for Plasmodium Vivax Malaria?
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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 606 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shoklo Malaria Research Unit Academic / other |
| Locations | 1 site (Mae Sot, Changwat Tak) |
| Trial ID | NCT05788094 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with concurrent P. falciparum malaria, severe anemia, or those who are pregnant or lactating will not benefit from this study.
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 performed: Previous studies have indicated the potential effectiveness of tafenoquine, but this specific comparison with ACT is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Mae Sot, Changwat Tak
- Shoklo Malaria Research Unit (SMRU) — Mae Sot, Changwat Tak, Thailand (Recruiting)
Study contacts
- Principal investigator: Francois Nosten, Prof — Shoklo Malaria Research Unit
- Study coordinator: Aung Pyae Phyo, DPhil
- Email: aungpyaephyo@tropmedres.ac
- Phone: +66 927 127 091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.