Overview

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

Status:
Not yet recruiting

Trial end date:
2024-02-26

Target enrollment:

Participant gender:

Summary

The purpose of this study is to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria. The study also intends 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 of another drug in malaria endemic countries. Cipargamin treatment results in rapid clearance of parasites including artemisinin resistant parasites.

Phase:

Phase 2

Details

Lead Sponsor:

Novartis Pharmaceuticals

Collaborators:

EDCTP within the PAMAFRICA Grant
European and Developing Countries Clinical Trials Partnership (EDCTP)
Wellcome Trust

Treatments:

Artemether
Artemether, Lumefantrine Drug Combination
Artesunate
Lumefantrine