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Southeast Asia Dose Optimization of Tafenoquine

NCT04704999 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-03-06

No results posted yet for this study

Summary

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.

Conditions

  • Plasmodium Vivax Malaria

Interventions

DRUG

Tafenoquine

Tafenoquine will be given as 100mg coated tablets. Tablets will be given based on weight bands.

DRUG

Chloroquine

Chloroquine will be given as daily dose over 3 days (25mg/kg total dose divided 10/10/5mg/kg)

DRUG

Artemether 20 mg-Lumefantrine 120 mg

Artemether-lumefantrine will be given twice daily over 3 days. Whole tablets will be given based on weight bands.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Cindy Chu, MD, PhD · Lao-Oxford-Mahosot Hospital-Wellcome Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2027-10-04
Completion
2028-02-07

Countries

  • Cambodia
  • Laos
  • Thailand
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704999 on ClinicalTrials.gov