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

NARecruitingINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

August 7, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

November 30, 2025

Conditions
Vivax MalariaG6PD Deficiency
Interventions
COMBINATION_PRODUCT

Revised case management package

"1. Point-of-care quantitative G6PD testing using G6PD STANDARD (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 G6PD activity is 30-70 percent~ * PQ8w (0.75 mg/kg/week for 8 weeks) if G6DP activity less than 30 percent~3. Participant counselling at the health facility (Day 0):~ * Supervision of first dose of primaquine~ * Education regarding 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 (4)

Unknown

RECRUITING

Napapar Health Centre, Kokopo

RECRUITING

Wirui Clinic, Wewak

RECRUITING

Mugil Health Centre, Madang

RECRUITING

Baro Clinic, Vanimo

All Listed Sponsors
collaborator

Papua New Guinea Institute of Medical Research

OTHER_GOV

collaborator

Papua New Guinea National Department of Health

UNKNOWN

collaborator

Menzies School of Health Research

OTHER

collaborator

University of Melbourne

OTHER

collaborator

Medicines for Malaria Venture

OTHER

collaborator

PATH

OTHER

collaborator

UNITAID

OTHER

lead

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

OTHER