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Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand

NCT05753150 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 187

Last updated 2023-10-26

No results posted yet for this study

Summary

The purpose of this prospective, observational study is to assess the operational feasibility of appropriate radical cure treatment for P. vivax malaria with tafenoquine or primaquine, in patients 16 year and older, after G6PD testing in Thailand. The study will be implemented in a phased manner, in the provinces of Yala and Mae Hong Son. The first phase will be at higher level health facilities (hospitals). An interim analysis will be conducted after 40 patients are enrolled in the study in order to decide whether the study could be extended to lower level HFs. If approved by the Independent Study Oversight Committee, the study will be implemented in lower level HFs (malaria clinics).Higher level HFs will continue to include patients in the study during this 2nd phase.Written informed consent / assent is required from all patients /guardians in the case of minors.

Conditions

  • Malaria, Vivax
  • G6PD Deficiency

Interventions

DRUG

Tafenoquine

Tafenoquine 300 mg (2x150 mg tablets)

DRUG

Primaquine

Daily primaquine adjusted by weight (0.25 mg/kg/day for 14 days)

DRUG

Primaquine

Weekly primaquine adjusted by weight (0.75mg/kg/week for 8 weeks)

Sponsors & Collaborators

  • Medicines for Malaria Venture

    collaborator OTHER

  • Dr. Prayuth Sudathip

    lead OTHER_GOV

Principal Investigators

  • Chantana Padungtod, M.D., DrPH · Director, Dept. Vector Borne Diseases (DVBD)

  • Saowanee Viboonsanti, M.D. · Director, ODPC Reg. No. 1

  • Chalermpol Chalermpol, M.D. · Director, ODPC Reg. No. 12

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2023-08-31
Completion
2023-10-01

Countries

  • Thailand

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 NCT05753150 on ClinicalTrials.gov