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

NCT05879224 | Completed DMC

• 1 other identifier: MMV_PQ_21_01 U1111-1291-3218
• Study Type: interventional
• Target: 2,999
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Primaquine

Outcome Measures

Primary Outcomes (3)

• Proportion of patients experiencing at least one Serious Adverse Event (SAE) during treatment

  SAEs are collected during clinical review using a study-specific questionnaire

  During treatment (up to 8 weeks) ]

• Proportion of patients experiencing at least one Adverse Event of Special Interest(AESI) during treatment

  AESIs (haemolysis, methaemoglobinaemia and gastrointestinal discomfort) are collected during clinical review using a study-specific questionnaire

  During treatment (up to 8 weeks)

• Proportion of patients with P. vivax malaria who correctly receive all components of the revised case management package

  Measured by completion of G6PD testing and the correct prescription of primaquine based on G6PD activity, completion of patients counselling and community based follow up on Day 3

  3 days

Secondary Outcomes (35)

• The proportion of patients with any AESI during treatment

  During treatment (up to 8 weeks)

• The proportion of patients with a gastrointestinal (GI) AESI during treatment

  During treatment (up to 8 weeks)

• The proportion of patients with an AESI related to haemolysis during treatment

  During treatment (up to 8 weeks) ]

• The proportion of patients an AESI related to methaemoglobinaemia

  During treatment (up to 8 weeks)

• Proportion of patients permanently stopping PQ before end of treatment

  During treatment (up to 8 weeks)

Study Arms (1)

Revised case management package

EXPERIMENTAL

Combination Product: Revised case management package

Interventions

Revised case management package COMBINATION_PRODUCT

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

Revised case management package

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with vivax malaria

You may not qualify if:

• 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

Sponsors & Collaborators

• Menzies School of Health Research: lead
• Gadjah Mada University: collaborator
• Universitas Sumatera Utara: collaborator
• Indonesia University: collaborator
• Yayasan Pengembangan Kesehatan dan Masyarakat: collaborator
• Indonesian National Malaria Control Program, Ministry of Health: collaborator
• National Research and Innovation Agency of Indonesia: collaborator
• Burnet Institute: collaborator
• University of Melbourne: collaborator
• Medicines for Malaria Venture: collaborator
• PATH: collaborator
• UNITAID: collaborator
• Institute of Tropical Medicine, Belgium: collaborator

Study Sites (6)

Puskesmas Hanura

Hanura, Lampung, Indonesia

Location

Puskesmas Tanjung Leidong

Labuhanbatu, North Sumatra, Indonesia

Location

Puskesmas Bhintuka

Mimika, Special Region of Papua, Indonesia

Location

Puskesmas Pasar Sentral

Mimika, Special Region of Papua, Indonesia

Location

Puskesmas Timika

Mimika, Special Region of Papua, Indonesia

Location

Puskesmas Wania

Mimika, Special Region of Papua, Indonesia

Location

Related Publications (1)

• SCOPE Study Group. High daily dose Short COurse PrimaquinE after G6PD testing for the radical cure of Plasmodium vivax malaria in Indonesia and Papua New Guinea: the SCOPE implementation study protocol. BMC Infect Dis. 2025 Jul 16;25(1):922. doi: 10.1186/s12879-025-11109-9.

  PMID: 40670924 DERIVED

MeSH Terms

Conditions

Malaria, Vivax; Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ric Price, MD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Combination Product: Revised case management package

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: August 7, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 17, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Access is subject to approval by the SCOPE Data Access Committee to ensure that the use of data protects the interests of the participants and researchers according to the terms of ethics approval and principles of equitable data sharing. Requests can be submitted to the Requests can be submitted to Professor Ric Price, Menzies School of Health Research, Email:ric.price@menzies.edu.au and Dr Jeanne Rini Poespoprodjo, Universitas Gadjah Mada, Email:didot2266@yahoo.com

Locations

ID (6)