Macfarlane Burnet Institute for Medical Research and Public Health Ltd
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.
Vivax Malaria
G6PD Deficiency
Revised case management package
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 5850 participants |
Masking : | None (Open Label) |
Primary Purpose : | Other |
Official Title : | Feasibility of High Daily Dose Short Course Primaquine After G6PD Testing for the Radical Cure of Plasmodium Vivax Malaria |
Actual Study Start Date : | July 10, 2023 |
Estimated Primary Completion Date : | May 31, 2025 |
Estimated Study Completion Date : | July 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Revised case management package |
Combination Product: Revised case management package |
Ages Eligible for Study: | 12 Months |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Napapar Health Centre
Shovel, East New Britain, Papua New Guinea,
Recruiting
Wirui Clinic
Weak, East Sepik, Papua New Guinea,
Recruiting
Baro Clinic
Vanimo, West Sepik, Papua New Guinea,
Recruiting
Mugil Health Centre
Madang, Papua New Guinea,