Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea
NCT ID: NCT05874271
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
794 participants
INTERVENTIONAL
2023-08-07
2025-10-25
Brief Summary
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P. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allows it to escape detection and treatment. Importantly, they are susceptible only to 8 aminoquinolines such as primaquine. However, primaquine is associated with risk of haemolysis in individuals with a genetic condition, called glucose-6-phosphate dehydrogenase (G6PD) deficiency. Additionally, the recommended 14-day prolonged treatment regimen is associated with poor treatment adherence, hence ineffective primaquine treatment. Innovative solutions to the radical cure of both the blood and liver stages of P. vivax are urgently required.
The PNG National Department of Health has requested a pragmatic study of the feasibility and cost-effectiveness of implementing point-of-care G6PD testing followed by high-dose, short-course primaquine treatment regimens for patients with P. vivax malaria. This revised case management is to be combined with practicable enhancements to patient education, supervision, malariometric surveillance and pharmacovigilance.
This will be a before-after longitudinal health facility-based study implemented at Napapar and Mugil health centres and Baro and Wirui clinics. A staged approach for the implementation of the revised case management strategy will be used, including patient education and counselling, community-based clinical review, with mixed methods evaluation.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Revised case management package
Revised case management package
1. Point-of-care quantitative G6PD testing using G6PD STANDARD (SD Biosensor) prior to use of primaquine (Day 0)
2. Prescription of short course primaquine (7 mg/kg total) (Day 0):
* PQ7 (1 mg/kg/day for 7 days) if G6PD activity greater than 70 percent
* PQ14 (0.5 mg/kg/day for 14 days) if G6PD activity is 30-70 percent
* PQ8w (0.75 mg/kg/week for 8 weeks) if G6DP activity less than 30 percent
3. Participant counselling at the health facility (Day 0):
* Supervision of first dose of primaquine
* Education regarding importance and risks of primaquine therapy and necessity to take primaquine with food
4. Community based clinical review on Day 3 (and Day 7 for the first 300 participants) to detect and manage gastrointestinal or haemolytic adverse effects of treatment and encourage adherence to full treatment regime
5. Improved malariometric surveillance and pharmacovigilance to support wider scale use of the revised case management
Interventions
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Revised case management package
1. Point-of-care quantitative G6PD testing using G6PD STANDARD (SD Biosensor) prior to use of primaquine (Day 0)
2. Prescription of short course primaquine (7 mg/kg total) (Day 0):
* PQ7 (1 mg/kg/day for 7 days) if G6PD activity greater than 70 percent
* PQ14 (0.5 mg/kg/day for 14 days) if G6PD activity is 30-70 percent
* PQ8w (0.75 mg/kg/week for 8 weeks) if G6DP activity less than 30 percent
3. Participant counselling at the health facility (Day 0):
* Supervision of first dose of primaquine
* Education regarding importance and risks of primaquine therapy and necessity to take primaquine with food
4. Community based clinical review on Day 3 (and Day 7 for the first 300 participants) to detect and manage gastrointestinal or haemolytic adverse effects of treatment and encourage adherence to full treatment regime
5. Improved malariometric surveillance and pharmacovigilance to support wider scale use of the revised case management
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who are breastfeeding
* Patients with a Hb \<8g/dL
* Patients with a previous adverse reaction to primaquine
* Patient with severe malaria
12 Months
ALL
No
Sponsors
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Papua New Guinea Institute of Medical Research
OTHER_GOV
Papua New Guinea National Department of Health
UNKNOWN
Menzies School of Health Research
OTHER
University of Melbourne
OTHER
Medicines for Malaria Venture
OTHER
PATH
OTHER
UNITAID
OTHER
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
OTHER
Responsible Party
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Principal Investigators
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Moses Laman, Dr
Role: PRINCIPAL_INVESTIGATOR
Papua New Guinea Institute of Medical Research
Leanne Robinson, Prof
Role: PRINCIPAL_INVESTIGATOR
Macfarlane Burnet Institute for Medical Research and Public Health
Leo Makita
Role: PRINCIPAL_INVESTIGATOR
Papua New Guinea National Department of Health
William Pomat, Prof
Role: PRINCIPAL_INVESTIGATOR
Papua New Guinea Institute of Medical Research
Locations
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Napapar Health Centre
Kokopo, East New Britain Province, Papua New Guinea
Wirui Clinic
Wewak, East Sepik Province, Papua New Guinea
Mugil Health Centre
Madang, Madang Province, Papua New Guinea
Baro Clinic
Vanimo, Sandaun Province, Papua New Guinea
Countries
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References
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SCOPE Study Group. High daily dose Short COurse PrimaquinE after G6PD testing for the radical cure of Plasmodium vivax malaria in Indonesia and Papua New Guinea: the SCOPE implementation study protocol. BMC Infect Dis. 2025 Jul 16;25(1):922. doi: 10.1186/s12879-025-11109-9.
Other Identifiers
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U1111-1285-4864
Identifier Type: OTHER
Identifier Source: secondary_id
MMV_PQ_21_02
Identifier Type: -
Identifier Source: org_study_id
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