NCT06148792 A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
| NCT ID | NCT06148792 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Menzies School of Health Research |
| Condition | Vivax Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,090 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2027-03-01 |
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 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,090 participants in total. It began in 2024-05-10 with a primary completion date of 2027-03-01.
⚠ 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
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. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Kamala N Thriemer, PhD
PRINCIPAL INVESTIGATOR
Menzies School of Health Research
Frequently Asked Questions
Who can join the NCT06148792 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vivax 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 NCT06148792 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,090 participants.
Is NCT06148792 currently recruiting?
Yes, NCT06148792 is actively recruiting participants. Contact the research team at hellen.mnjala@menzies.edu.au for enrollment information.
Where is the NCT06148792 trial being conducted?
This trial is being conducted at Manaus, Brazil, Arba Minch, Ethiopia, Hanura, Indonesia, Alexishafen, Papua New Guinea.
Who is sponsoring the NCT06148792 clinical trial?
NCT06148792 is sponsored by Menzies School of Health Research. The principal investigator is Kamala N Thriemer, PhD at Menzies School of Health Research. The trial plans to enroll 1,090 participants.