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New treatment option for Vivax Malaria
Official title A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
ClinicalTrials.gov ID: NCT06148792
What this study is testing
What is Tafenoquine?
Tafenoquine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for vivax malaria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question(s) it aims to answer are: is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days) is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg) is the tolerability and safety of TQRevised acceptable is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- P. vivax peripheral parasitaemia (mono-infection)
- G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
- Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
- Written informed consent
- Living in the study area and willing to be followed for six months
You likely can't join if
- Danger signs or symptoms of severe malaria
- Anaemia (defined as Hb \<8g/dl)
- Pregnant or lactating females
- Regular use of drugs with haemolytic potential
- Known hypersensitivity to any of the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Manaus, Brazil
- Arba Minch, Ethiopia
- Hanura, Indonesia
- Alexishafen, Papua New Guinea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manaus, Brazil; Arba Minch, Ethiopia; Hanura, Indonesia; Alexishafen, Papua New Guinea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.