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

Last updated: July 9, 2023
Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Red Blood Cell Disorders

Treatment

Revised case management package

Clinical Study ID

NCT05874271
MMV_PQ_21_02
U1111-1285-4864
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with vivax malaria

Exclusion

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

Study Design

Total Participants: 5850
Treatment Group(s): 1
Primary Treatment: Revised case management package
Phase:
Study Start date:
July 10, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Napapar Health Centre

    Kokopo, East New Britain
    Papua New Guinea

    Active - Recruiting

  • Wirui Clinic

    Wewak, East Sepik
    Papua New Guinea

    Active - Recruiting

  • Baro Clinic

    Vanimo, West Sepik
    Papua New Guinea

    Active - Recruiting

  • Mugil Health Centre

    Madang,
    Papua New Guinea

    Active - Recruiting

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