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Southeast Asia Dose Optimization of Tafenoquine

Study acronym: SEADOT
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study description expanded, about 17 words
  2. Enrollment increased: 700 → 820 participantsv13 Show 5 more changesShow less
    • Trial arms changed: 2 → 3
    • Study sites: 5 to 6
    • Interventions: Artemether 20 mg-Lumefantrine 120 mg (Drug), Chloroquine (Drug), Tafenoquine (Drug) to Artemether 20 mg-Lumefantrine 120 mg (Drug), Chloroquine (Drug), Dihydroartemisinin 40 mg-Piperaquine 320 mg (Drug), Primaquine (Drug)…
    • Secondary endpoints: 9 to 10
    • Study description expanded, about 132 words
  3. Re-verified, no change to tracked fieldsv12
  4. Trial status: Not Yet Recruiting to Recruitingv11 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2027 to Oct 4, 2027
    • Study completion date: Dec 31, 2027 to Feb 7, 2028
    • Start date changed from estimate of Aug 1, 2024 to Jul 22, 2024
    • Site details revised at 5 of 5 sites
  5. Start date: May 1, 2024 to Aug 1, 2024v10
Show 8 earlier versionsHide 8 earlier versions
  1. Start date: Feb 1, 2024 to May 1, 2024v9
  2. Study sites: 6 to 5
    • Study description shortened, about 10 words
    v8
  3. Start date: Sep 18, 2023 to Feb 1, 2024v7
  4. Start date: Jan 8, 2024 to Sep 18, 2023v6
  5. Secondary endpoints revised (9)
    • Study description shortened, about 123 words
    • Eligibility criteria expanded, about 4 words
    • Collaborators shortened, about 1 word
    v5
  6. Primary and study completion dates: Mar 31, 2027 to Dec 31, 2027v4 Show 7 more changesShow less
    • Start date: Apr 1, 2023 to Jan 8, 2024
    • Primary endpoint revised
    • Enrollment target: 600 to 700
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 71 words
    • Study arms: 3 to 2
    • Eligibility criteria shortened, about 2 words
  7. Start date: Oct 1, 2022 to Apr 1, 2023v3
  8. Primary and study completion dates: Mar 31, 2026 to Mar 31, 2027
    • Start date: Oct 1, 2021 to Oct 1, 2022
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg/kg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg/kg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia. Addendum for Indonesia: The INSPECTOR trial results showed that tafenoquine 300mg was not efficacious for radical cure (79% probability for recurrence after treatment). The comparator arm, low-dose primaquine 3.5mg/kg divided equally over 14 days, showed a 48% probability of recurrence after treatment). The standard of care for radical cure in Indonesia is high-dose primaquine 7mg/kg divided in 7 daily doses).
Trial Details
NCT Number NCT04704999
Lead Sponsor University of Oxford
Conditions
(from sponsor)		 Plasmodium Vivax Malaria
Related terms Malaria, Vivax, Recurrence
Enrollment 820 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov