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NCT05874271 | Recruiting | Vivax Malaria


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

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

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.

Condition or disease

Vivax Malaria

G6PD Deficiency

Intervention/treatment

Revised case management package

Phase

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
Criteria
Inclusion Criteria
  • Patients with vivax malaria
Exclusion Criteria
  • 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

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Papua New Guinea, East New Britain

Napapar Health Centre

Shovel, East New Britain, Papua New Guinea,

Recruiting

Papua New Guinea, East Sepik

Wirui Clinic

Weak, East Sepik, Papua New Guinea,

Recruiting

Papua New Guinea, West Sepik

Baro Clinic

Vanimo, West Sepik, Papua New Guinea,

Recruiting

Papua New Guinea,

Mugil Health Centre

Madang, Papua New Guinea,

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