A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
NCT ID: NCT06148792
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1090 participants
INTERVENTIONAL
2024-05-10
2027-03-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TQRevised
Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)
Tafenoquine
oral treatment
TQStandard
Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)
Tafenoquine
oral treatment
PQ7
Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)
Primaquine
oral treatment
Interventions
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Tafenoquine
oral treatment
Primaquine
oral treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Melbourne
OTHER
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
OTHER
Arba Minch University
OTHER
Addis Ababa University
OTHER
Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia
UNKNOWN
Curtin University
OTHER
Papua New Guinea Institute of Medical Research
OTHER_GOV
Menzies School of Health Research
OTHER
Responsible Party
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Principal Investigators
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Kamala N Thriemer, PhD
Role: PRINCIPAL_INVESTIGATOR
Menzies School of Health Research
Locations
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Dr Marcus Lacerda
Manaus, , Brazil
Arba Minch General Hospital
Arba Minch, , Ethiopia
Puskesmas Hanura
Hanura, , Indonesia
Dr Moses Laman and Dr Brioni Moore
Alexishafen, , Papua New Guinea
Countries
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Central Contacts
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Facility Contacts
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Tamiru Shibiru Degaga, MD
Role: primary
Erni Dr Juwita
Role: backup
Other Identifiers
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TADORE
Identifier Type: -
Identifier Source: org_study_id
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