Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia

Summary

The proportion of malaria that is the Plasmodium vivax species is increasing in Indonesia. Reducing vivax malaria will require innovative solutions to cure both the blood and liver stages of the disease. This study will evaluate of the feasibility of implementing point-of-care glucose-6-phosphate dehydrogenase deficiency (G6PD) testing. This will be followed by high dose, short course primaquine treatment regimens for patients with vivax malaria, and combined with patient education, surveillance, and pharmacovigilance. We plan to implement the study at 6 health facilities across Indonesia using a staged before-and-after study, with a mixed method evaluation.

Conditions

• Vivax Malaria
• G6PD Deficiency

Interventions

COMBINATION_PRODUCT

Revised case management package

1. Point-of-care quantitative G6PD testing using G6PDSTANDARD (SD Biosensor) prior to use of primaquine (Day 0) 2. Prescription of short course primaquine (7 mg/kg total)(Day 0): * PQ7 (1 mg/kg/day for 7 days) if G6PD activity greater than 70 percent * PQ14 (0.5 mg/kg/day for 14 days) if G6PDactivity is 30-70 percent * PQ8w (0.75 mg/kg/week for 8 weeks) if G6DPactivity less than 30 percent 3. Participant counselling at the health facility (Day 0): * Supervision of first dose of primaquine * Education regarding the importance and risks of primaquine therapy and necessity to take primaquine with food 4. Community based clinical review on Day 3 (and Day 7 for the first 300 participants) to detect and manage gastrointestinal or haemolytic adverse effects of treatment and encourage adherence to full treatment regime 5. Improved malariometric surveillance and pharmacovigilance to support wider scale use of the revised case management

Sponsors & Collaborators

• Gadjah Mada University

  collaborator OTHER

• Universitas Sumatera Utara

  collaborator OTHER

• Indonesia University

  collaborator OTHER

• Yayasan Pengembangan Kesehatan dan Masyarakat

  collaborator UNKNOWN

• Indonesian National Malaria Control Program, Ministry of Health

  collaborator UNKNOWN

• National Research and Innovation Agency of Indonesia

  collaborator UNKNOWN

• Burnet Institute

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Medicines for Malaria Venture

  collaborator OTHER

• PATH

  collaborator OTHER

• UNITAID

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Menzies School of Health Research

  lead OTHER

Principal Investigators

• Ric Price, MD · Menzies School of Health Research

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-07

Primary Completion

2025-11-01

Completion

2025-12-17

Countries

• Indonesia

Study Locations