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A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Study acronym: TADORE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Site details revised at 1 of 4 sitesv6
  2. Study sites revised (4)
    • Collaborators: 8 to 7
    v5
  3. Site details revised at 1 of 4 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2024 to May 10, 2024
    • Site details revised at 4 of 4 sites
    v3
  5. Interventions: Primaquin (Drug), Tafenoquine (Drug) to Primaquine (Drug), Tafenoquine (Drug)v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06148792
Lead Sponsor Menzies School of Health Research
Collaborators: University of Melbourne, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Arba Minch University, Addis Ababa University, Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia, Curtin University, Papua New Guinea Institute of Medical Research
Conditions
(from sponsor)		 Vivax Malaria
Related terms Malaria, Vivax
Enrollment 1,090 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov