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

Vivax Malaria Clinical Trial

Official title: Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• G6PD Deficiency
• Glucosephosphate Dehydrogenase Deficiency
• Malaria
• Malaria, Vivax
• Vivax Malaria

• NCT number: NCT05874271
• Study type: Interventional
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: Evelien Rosens, MSc
• Phone: +61 3 9282 2111
• Email: evelien.rosens@burnet.edu.au
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Completion date: July 31, 2025