254
Participants
Start Date
March 7, 2022
Primary Completion Date
July 24, 2025
Study Completion Date
August 20, 2025
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."
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.
Coartem
Oral Standard of Care
Novartis Investigative Site, Manhiça
Novartis Investigative Site, Burkina Faso
Novartis Investigative Site, Siaya
Novartis Investigative Site, Tororo
Novartis Investigative Site, Ilorin
Novartis Investigative Site, Ouagadougou
Novartis Investigative Site, Bagamoyo
Novartis Investigative Site, Abidjan
Novartis Investigative Site, Agboville
Novartis Investigative Site, Kinsasha
Novartis Investigative Site, Lambaréné
Novartis Investigative Site, Kigali
Lead Sponsor
Wellcome Trust
OTHER
European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Novartis Pharmaceuticals
INDUSTRY