Safety of Antimalarials in the FIRst trimEster

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,510

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2029

Conditions
Malaria, PregnancyMalaria, AntepartumMalaria (Uncomplicated)
Interventions
DRUG

dihydroartemisinin-piperaquine (DP)

Weight-based dosing of 3 (\<60kg), 4 (6-80kg) or 5 (\>80 kg) 40/320 mg tablets of dihydroartemisinin-piperaquine given once daily for 3 days

DRUG

Pyronaridine-artesunate (PA)

Weight-based dosing of 2 (24-\<45 kg), 3 (45-\<65kg), or 4 (\>=65 kg) 180/60 mg tablets of pyronaridine-artesunate, once daily for 3 days.

DRUG

Artemether-lumefantrine

1 x 80/480 or 4 x 20/120 mg tablets of artemether-lumefantrine, given twice daily, approximately 8 hours apart for 3 days

Trial Locations (3)

1805

Malaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako (USTTB),, Bamako

40100

KEMRI Centre for Global Health Research (CGHR), Kisumu

Unknown

Clinical Research Unit of Nanoro (CRUN), Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS-DRO), Nanoro

All Listed Sponsors
collaborator

Malaria Research and Training Center, Mali International Center of Excellence in Research, University of Sciences, Techniques, and Technologies of Bamako, Mali

UNKNOWN

collaborator

KEMRI Centre for Global Health Research (CGHR), Kisumu, Kenya

UNKNOWN

collaborator

Clinical Research Unit of Nanoro (CRUN), Institut de Recherche en Sciences de la Santé

UNKNOWN

collaborator

Medicines for Malaria Venture (co-sponsor)

UNKNOWN

collaborator

US Centers for Disease Control and Prevention (CDC), Division of Parasitic Diseases & Malaria

UNKNOWN

lead

Liverpool School of Tropical Medicine

OTHER