Status:
COMPLETED
Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Institut Pasteur du Cambodge
Conditions:
Vivax Malaria
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (W...
Detailed Description
The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization-ap...
Eligibility Criteria
Inclusion
- Age 15 and older
- Acute (within 10 days), symptomatic (i.e., history of fever), uncomplicated malaria caused solely by Plasmodium vivax (verified by PCR)
- G6PD normal (as determined by quantitative spectrophotometric assay)
Exclusion
- Pregnant, planning to become pregnant or lactating women,
- Received antimalarial drugs in the past month,
- Hb \< 8g/dL, \< 1,500 neutrophils/μl, or signs of complicated malaria (e.g., vomiting, convulsions,…),
- History of primaquine, artesunate or artesunate-mefloquine allergy or intolerance,
- PCR-positivity for severe acute respiratory syndrome coronavirus 2.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04706130
Start Date
April 15 2021
End Date
October 1 2024
Last Update
March 28 2025
Active Locations (1)
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1
Institut Pasteur du Cambodge
Phnom Penh, Cambodia