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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:

• Patients with vivax malaria

Locations
Other Locations
Papua New Guinea
Napapar Health Centre
RECRUITING
Kokopo
Mugil Health Centre
RECRUITING
Madang
Baro Clinic
RECRUITING
Vanimo
Wirui Clinic
RECRUITING
Wewak
Contact Information
Primary
Evelien Rosens, MSc
evelien.rosens@burnet.edu.au
+61 3 9282 2111
Backup
Mary Malai, Dr
mary.malai@pngimr.org.pg
+675 531 4200
Time Frame
Start Date: 2023-08-07
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 900
Treatments
Experimental: Revised case management package
Sponsors
Collaborators: PATH, Papua New Guinea National Department of Health, Menzies School of Health Research, UNITAID, Medicines for Malaria Venture, University of Melbourne, Papua New Guinea Institute of Medical Research
Leads: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

This content was sourced from clinicaltrials.gov