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

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

Interventions

COMBINATION_PRODUCT

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

Sponsors & Collaborators

• Papua New Guinea Institute of Medical Research

  collaborator OTHER_GOV

• Papua New Guinea National Department of Health

  collaborator UNKNOWN

• Menzies School of Health Research

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Medicines for Malaria Venture

  collaborator OTHER

• PATH

  collaborator OTHER

• UNITAID

  collaborator OTHER

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd

  lead OTHER

Principal Investigators

• Moses Laman, Dr · Papua New Guinea Institute of Medical Research

• Leanne Robinson, Prof · Macfarlane Burnet Institute for Medical Research and Public Health

• Leo Makita · Papua New Guinea National Department of Health

• William Pomat, Prof · Papua New Guinea Institute of Medical Research

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-07

Primary Completion

2025-10-25

Completion

2025-10-25

Countries

• Papua New Guinea

Study Locations