Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea

NCT05874271 | Completed DMC

• 2 other identifiers: MMV_PQ_21_02U1111-1285-4864
• Study Type: interventional
• Target: 794
• Locations: 1 country
• Sites: 4

Brief Summary

Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax. 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.

Conditions

Vivax Malaria; G6PD Deficiency

Keywords

primaquine

Outcome Measures

Primary Outcomes (3)

• Proportion of patients experiencing at least one Serious Adverse Event (SAE) during treatment.

  SAEs are collected during clinical review using a study-specific questionnaire

  During treatment (up to 8 weeks)

• Proportion of patients experiencing at least one Adverse Event of Special Interest (AESI) during treatment.

  AESIs (haemolysis, methaemoglobinaemia and gastrointestinal discomfort) are collected during clinical review using a study-specific questionnaire

  During treatment (up to 8 weeks)

• Proportion of patients with P. vivax malaria who correctly receive all components of the revised case management package

  Measured by completion of G6PD testing and the correct prescription of primaquine based on G6PD activity, completion of patients counselling and community based follow up on Day 3

  3 days

Secondary Outcomes (35)

• The proportion of patients with any AESI during treatment

  During treatment (up to 8 weeks)

• The proportion of patients with a gastrointestinal (GI) AESI during treatment

  During treatment (up to 8 weeks)

• The proportion of patients with an AESI related to haemolysis during treatment

  During treatment (up to 8 weeks)

• The proportion of patients an AESI related to methaemoglobinaemia

  During treatment (up to 8 weeks)

• Proportion of patients permanently stopping PQ before end of treatment

  During treatment (up to 8 weeks)

Study Arms (1)

Revised case management package

EXPERIMENTAL

Combination Product: Revised case management package

Interventions

Revised case management package COMBINATION_PRODUCT

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

Revised case management package

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with vivax malaria

You may not qualify if:

• Patients who are pregnant
• Patients who are breastfeeding
• Patients with a Hb \<8g/dL
• Patients with a previous adverse reaction to primaquine
• Patient with severe malaria

Sponsors & Collaborators

• Papua New Guinea Institute of Medical Research: collaborator
• Papua New Guinea National Department of Health: collaborator
• Menzies School of Health Research: collaborator
• University of Melbourne: collaborator
• Medicines for Malaria Venture: collaborator
• PATH: collaborator
• UNITAID: collaborator
• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead

Study Sites (4)

Napapar Health Centre

Kokopo, East New Britain Province, Papua New Guinea

Location

Wirui Clinic

Wewak, East Sepik Province, Papua New Guinea

Location

Mugil Health Centre

Madang, Madang Province, Papua New Guinea

Location

Baro Clinic

Vanimo, Sandaun Province, Papua New Guinea

Location

Related Publications (1)

• 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.

  PMID: 40670924 RESULT

MeSH Terms

Conditions

Malaria, Vivax; Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Moses Laman, Dr

  Papua New Guinea Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Leanne Robinson, Prof

  Macfarlane Burnet Institute for Medical Research and Public Health

  PRINCIPAL INVESTIGATOR

• Leo Makita

  Papua New Guinea National Department of Health

  PRINCIPAL INVESTIGATOR

• William Pomat, Prof

  Papua New Guinea Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 24, 2023
• Study Start: August 7, 2023
• Primary Completion: October 25, 2025
• Study Completion: October 25, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Access is subject to approval by the SCOPE Data Access Committee to ensure that the use of data protects the interests of the participants and researchers according to the terms of ethics approval and principles of equitable data sharing. Requests can be submitted to the Burnet Institute and Papua New Guinea Institute of Medical Research email:evelien.rosens@burnet.edu.au / mary.malai@pngimr.org.pg

Locations

PA (4)