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

NARecruitingINTERVENTIONAL
Enrollment

11,250

Participants

Timeline

Start Date

August 7, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

July 31, 2025

Conditions
Vivax MalariaG6PD 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"

Trial Locations (6)

Unknown

RECRUITING

Puskesmas Hanura, Hanura

RECRUITING

Puskesmas Tanjung Leidong, Labuhanbatu

RECRUITING

Puskesmas Bhintuka, Mimika

RECRUITING

Puskesmas Pasar Sentral, Mimika

RECRUITING

Puskesmas Timika, Mimika

RECRUITING

Puskesmas Wania, Mimika

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gadjah Mada University

OTHER

collaborator

Universitas Sumatera Utara

OTHER

collaborator

Indonesia University

OTHER

collaborator

Yayasan Pengembangan Kesehatan dan Masyarakat

UNKNOWN

collaborator

Indonesian National Malaria Control Program, Ministry of Health

UNKNOWN

collaborator

National Research and Innovation Agency of Indonesia

UNKNOWN

collaborator

Burnet Institute

OTHER

collaborator

University of Melbourne

OTHER

collaborator

Medicines for Malaria Venture

OTHER

collaborator

PATH

OTHER

collaborator

UNITAID

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

lead

Menzies School of Health Research

OTHER