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Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

NCT04706130 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-03-28

No results posted yet for this study

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 (WHO)-approved drugs will be used at dosage and for conditions approved.

Conditions

  • Vivax Malaria

Interventions

DRUG

Primaquine

After treatment of the blood stage infection, enrolled participants will receive either no primaquine, a low dose of primaquine or a high dose of primaquine against liver parasites

DRUG

Artesunate

All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites

Sponsors & Collaborators

  • National Centre for Parasitology, Entomology and Malaria Control, Cambodia

    collaborator OTHER

  • Institut Pasteur du Cambodge

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • Cambodia

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 NCT04706130 on ClinicalTrials.gov