Phase 4 N=156 Randomized Treatment

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

Vivax Malaria

Bottom Line

View on ClinicalTrials.gov: NCT04706130 ↗

Enrolled (actual)

156

Serious AEs

0.0%

Results posted

Jun 2026

Primary outcome: Primary: Number of Patients Experiencing P. Vivax Recurrence — 48; 11; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Primaquine (Drug); Artesunate (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Experiencing P. Vivax Recurrence	48; 11; 2	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04706130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.