ACT vs CQ With Tafenoquine for P. Vivax Mono-infection

PHASE4RecruitingINTERVENTIONAL
Enrollment

606

Participants

Timeline

Start Date

June 26, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

August 31, 2026

Conditions
MalariaMalaria, VivaxPlasmodium Vivax Malaria
Interventions
DRUG

Dihydroartemisinin-piperaquine plus tafenoquine (450 mg adult dose)

"* Dihydroartemisinin-Piperaquine will be purchased as Duo-Cotecxin® Beijing Holley-Cotec Pharmaceuticals Co., Ltd, China). One tablet contains 40 mg of dihydroartemisinin and 320 mg piperaquine (i.e. a 1:8 ratio). A weight-based regimen containing a total dose of approximately 7 mg/kg DHA and 55 mg/kg piperaquine given in 3 divided doses once daily.~* Tafenoquine KODATEF® 150 mg film-coated tablets will be purchased from Biocelect (Suite 5.02, Level 5, 139 Macquarie Street, Sydney NSW, 2000 Australia), 450 mg (4 1/2 tablets) will be given."

DRUG

Chloroquine plus Tafenoquine (450 mg adult dose)

"* Chloroquine will be dosed as a 25 mg/kg base given in divided doses of 10 mg/kg orally on days 0 and 1, and in 5 mg/kg dose on day 2. Tablets will be obtained from Government Pharmaceutical Organization (GPO) in Bangkok, Thailand and supplied as 250 mg tablets (155.3 mg base).~* Tafenoquine KODATEF® 150 mg film-coated tablets will be purchased from Biocelect (Suite 5.02, Level 5, 139 Macquarie Street, Sydney NSW, 2000 Australia), 450 mg (4 1/2 tablets) will be given."

DRUG

Artemether-Lumefantrine plus Tafenoquine (450 mg adult dose)

"* Artemether-Lumefantrine will be given at a standard dose of 20/120 mg twice daily for three days. (AL will be purchase from Novartis Pharma Services AG- Lichtstrasse 35, CH-4056 Basel, Switzerland.)~* Tafenoquine KODATEF® 100 mg film-coated tablets will be purchased from Biocelect (Suite 5.02, Level 5, 139 Macquarie Street, Sydney NSW, 2000 Australia), 450 mg (4 1/2 tablets) will be given."

Trial Locations (1)

63110

RECRUITING

Shoklo Malaria Research Unit (SMRU), Mae Sot

All Listed Sponsors
collaborator

Mahidol Oxford Tropical Medicine Research Unit

OTHER

collaborator

University of Oxford

OTHER

lead

Shoklo Malaria Research Unit

OTHER