Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania

PHASE2CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

January 31, 2020

Study Completion Date

February 29, 2020

Conditions
MalariaPregnancy MalariaCardiotoxicityCardiac SafetyParasitemia
Interventions
DRUG

sulfadoxine-pyrimethamine (SP)

"Women in Groups 1 and 2 will be provided the following SP regimen as directly observed therapy:~3 tablets total of 500 mg sulphadoxine and 25 mg pyrimethamine; 1 day of dosing."

DRUG

dihydroartemisinin-piperaquine (DHA-PQP)

Women in Groups 3 and 4 will be provided the following DHA-PQP regimen as directly observed therapy 3 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine daily; 9 tablets total; 3 days of dosing.

Trial Locations (1)

Unknown

Handeni District Hospital, Handeni

All Listed Sponsors
collaborator

Kilimanjaro Christian Medical Centre, Tanzania

OTHER

collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

lead

London School of Hygiene and Tropical Medicine

OTHER

NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania | Biotech Hunter | Biotech Hunter