To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria

PHASE2CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

July 24, 2025

Study Completion Date

August 20, 2025

Conditions
Severe Malaria
Interventions
DRUG

KAE609

"Two doses of Intravenous Cipargamin will be evaluated in the initial phase of the study (Cohorts 1-2).~These doses will cover a wider exposure range and facilitate the selection of an appropriate dose for later Cohorts 3-5."

DRUG

IV Artesunate

Parenteral artesunate is the WHO recommended first line treatment for severe malaria. Hence IV artesunate is used as comparator. Also, this will be used as rescue medication for participants where IV KAE609 is not working.

DRUG

Coartem

Oral Standard of Care

Trial Locations (12)

1929

Novartis Investigative Site, Manhiça

2208

Novartis Investigative Site, Burkina Faso

2300

Novartis Investigative Site, Siaya

10102

Novartis Investigative Site, Tororo

240003

Novartis Investigative Site, Ilorin

Unknown

Novartis Investigative Site, Ouagadougou

Novartis Investigative Site, Bagamoyo

13BP972

Novartis Investigative Site, Abidjan

BP 154

Novartis Investigative Site, Agboville

BP 7948

Novartis Investigative Site, Kinsasha

BP 242

Novartis Investigative Site, Lambaréné

BP 4560

Novartis Investigative Site, Kigali

Sponsors
All Listed Sponsors
collaborator

Wellcome Trust

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

lead

Novartis Pharmaceuticals

INDUSTRY