Phase 4
Completed N=156
Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
Vivax Malaria
Source: ClinicalTrials.gov NCT04706130 ↗
Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcomePrimary: Number of Patients Experiencing P. Vivax Recurrence — 48; 11; 2 Participants
◆ Published Evidence
Emerging
10citations · ~10 / year
14 days of high-dose versus low-dose primaquine treatment in patients with Plasmodium vivax infection in Cambodia: a randomised, single-centre, open-label efficacy 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.
Linked Publications (2)
-
14 days of high-dose versus low-dose primaquine treatment in patients with Plasmodium vivax infection in Cambodia: a randomised, single-centre, open-label efficacy study.
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High versus low dose of 14 days treatment of primaquine in <i>Plasmodium vivax</i> infected patients in Cambodia: a randomised open-label efficacy study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing P. Vivax Recurrence |
48; 11; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04706130) and the linked publication. 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. Informational only — not medical advice.