drugset / Trial / NCT04706130
Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
Phase 4
Completed
160 enrolled
University of Maryland, Baltimore
Institut Pasteur du Cambodge · collabNational Centre for Parasitology, Entomology and Malaria Control, Cambodia · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-04-15
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
Publications
- Eng V, Lek D, Sin S, Feufack-Donfack LB, Orban A, Salvador J, Seng D, Heng S, Khim N, Tebben K, Flamand C, Sommen C, van der Pluijm RW, White M, Witkowski B, Serre D, Popovici J. 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. Lancet Infect Dis. 2025 Aug;25(8):884-895. doi: 10.1016/S1473-3099(25)00033-7. Epub 2025 Mar 17.
- Eng V, Lek D, Sin S, Feufack-Donfack LB, Orban A, Salvador J, Seng D, Heng S, Khim N, Tebben K, Flamand C, Sommen C, van der Pluijm RW, White M, Witkowski B, Serre D, Popovici J. High versus low dose of 14 days treatment of primaquine in Plasmodium vivax infected patients in Cambodia: a randomised open-label efficacy study. medRxiv [Preprint]. 2025 Jan 2:2025.01.01.25319862. doi: 10.1101/2025.01.01.25319862.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Primaquine | Small molecule | 0.25 mg/kg | — |
| Subject | Primaquine | Small molecule | 0.5 mg/kg | — |
| Background | Artesunate | Small molecule | 2 mg/kg | — |