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| Name | Class |
|---|---|
| National Centre for Parasitology, Entomology and Malaria Control, Cambodia | OTHER |
| Institut Pasteur du Cambodge | OTHER |
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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.
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-approved drugs will be used at dosage and for conditions approved.
Eligible patients willing to participate will first be tested prior to enrolment for their glucose-6-phosphate dehydrogenase (G6PD) status by the gold standard spectrophotometric analysis. The investigators will exclude from the study any G6PD deficient (or intermediate females) patient. Treatment allocation will be randomized between i) 7 days of artesunate (2 mg/kg/day for 7 days) alone (Arm1), ii) same artesunate regimen + 0.25 mg/kg/day 14 days of primaquine (Arm2) and iii) same artesunate regimen + 0.5 mg/kg/day 14 days of primaquine (Arm3). All patients will be relocated to a no-transmission city to make sure they are not reinfected during the follow-up. Follow-up will be performed every 24-48h for 90 days. At the end of the follow-up period, all patients that did not receive primaquine (arm1) will be treated according to national guidelines (14 days at 0.25mg/kg/day). Patients will additionally be followed monthly for three months after the end of the relocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1: No primaquine | Other | Enrolled patients will only received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) |
|
| Arm2: Primaquine low dose | Other | Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.25 mg/kg/day for 14 days (starting at day 7) |
|
| Arm3: Primaquine high dose | Other | Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.50 mg/kg/day for 14 days (starting at day 7) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primaquine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing P. Vivax Recurrence | Number of patients experiencing recurrence as measured by microscopy and PCR and time to recurrence | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Pasteur du Cambodge | Phnom Penh | Cambodia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40112852 | Derived | 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. | |
| 39802788 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) without primaquine |
| FG001 | Low Primaquine Group | Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.25 mg/kg/day of primaquine |
| FG002 | High Primaquine Group | Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.5 mg/kg/day of primaquine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm1: No Primaquine | Enrolled patients will only received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) Artesunate: All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites |
| BG001 | Arm2: Primaquine Low Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age in categories |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Experiencing P. Vivax Recurrence | Number of patients experiencing recurrence as measured by microscopy and PCR and time to recurrence | Posted | Count of Participants | Participants | 3 months |
|
From enrollment until end of follow-up (up to 90 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) without primaquine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Serre | University of Maryland School of Medicine | (410) 706-7983 | dserre@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2020 | May 7, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016780 | Malaria, Vivax |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011319 | Primaquine |
| D000077332 | Artesunate |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy.
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| Artesunate | Drug | All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites |
|
| Derived |
| 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. |
Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.25 mg/kg/day for 14 days (starting at day 7) 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 Artesunate: All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites |
| BG002 | Arm3: Primaquine High Dose | Enrolled patients will received blood stage antimalarial (artesunate at 2 mg/kg per day every 24h for 7 days) and primaquine at 0.50 mg/kg/day for 14 days (starting at day 7) 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 Artesunate: All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age with range | Mean | Inter-Quartile Range | years |
|
| Sex: Female, Male | Sex of participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethinicity | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.5 mg/kg/day of primaquine |
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 49 |
| 59 |
| EG001 | Low Primaquine Group | Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.25 mg/kg/day of primaquine | 0 | 45 | 0 | 45 | 27 | 45 |
| EG002 | High Primaquine Group | Participants are treated with 7 days of artesunate (2 mg/kg/day for 7 days) and 14 days of 0.5 mg/kg/day of primaquine | 0 | 43 | 0 | 43 | 31 | 43 |
| Fever | General disorders | Systematic Assessment |
|
| Influenza-like syndromes | Infections and infestations | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Methemoglobin increase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hemoglobin decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutrophil decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |