At a glance
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An Adaptive, Randomized, Active-controlled, Open-label, Sequential Cohort, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Intravenous Cipargamin (KAE609) in Adult and Pediatric Participants With Severe Plasmodium Falciparum Malaria (KARISMA - KAE609's Role In Severe Malaria)
In Brief
A Phase 2 clinical trial evaluating Cipargamin, IV Artesunate, and 1 other intervention for Severe Malaria. Completed, enrolled 254 participants across 9 sites in 7 countries.
Detailed Summary
The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria. The study also intended to evaluate clinical treatment success using a novel clinical endpoint for drug development in severe malaria. Severe malaria is a medical emergency and is affecting primarily young children in Africa. Injectable artesunate is the standard of care for the treatment of severe malaria and is highly efficacious. However, the spread of artemisinin-resistance in Plasmodium falciparum in Asian countries poses a threat for future treatment of patients with this life-threatening disease. To mitigate this risk, there is a need for another drug in malaria-endemic countries. Cipargamin treatment results in rapid clearance of parasites, including artemisinin-resistant parasites.
Study Details
Timeline
Interventions
Cipargamin, 20 mg or 40 mg, by intravenous administration of solution for injection
Artesunate, 2.4 mg/kg or 3 mg/kg, by intravenous administration of reconstituted solution
Oral standard of care (Coartem tablets, dosed per weight, as per label)