Exposure-Response Evaluation of IV Artesunate in Children With Severe Malaria

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, Ugandan children who are diagnosed with severe malaria will receive intravenous (IV) artesunate per World Health Organization (WHO) guidelines.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: Makerere University; National Institute of Allergy and Infectious Diseases (NIAID); University of Maryland, Baltimore
• Treatments: Artesunate

Criteria

Inclusion Criteria:

• Children ages 6 months to 14 years at the time of severe malaria diagnosis, inclusive

• Meet the case definition for severe malaria, per WHO standardized guidelines

• Parent/guardian willing to provide informed consent

• Assent for children between 8 and 14 years who are conscious and otherwise able to provide assent, inclusive

• Living in or near Tororo District, Uganda

Exclusion Criteria:

• Receipt of >24 hours of artemisinin therapy