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

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Status: Completed

Conditions: Vivax Malaria; G6PD Deficiency

Treatments: Combination Product: Revised case management package

Study type: Interventional

Funder types: Other

Identifiers

NCT05874271

MMV_PQ_21_02

U1111-1285-4864 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 794 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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794 participants in 1 patient group

Revised case management package

Experimental group

Treatment:

Combination Product: Revised case management package