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Completed NCT05750459

Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria

Conditions: Plasmodium Falciparum Infection

Sex: All
Ages: 6 Months – 14 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 90
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Location: Makerere University-Infectious Diseases Institute Kampala

Summary

This clinical study is a phase 4, single-site, open-label pharmacokinetic (PK) study of IV artesunate in up to 100 Ugandan children 6 months-14 years of age who are diagnosed with severe malaria according to standardized World Health Organization (WHO) criteria (any P. falciparum parasitemia and the presence of danger signs). Participants will receive the standard of care IV artesunate for initial treatment of severe malaria per WHO guidelines: children weighing \

Eligibility Criteria

Inclusion Criteria: 1. Children ages 6 months-14 years at the time of severe malaria diagnosis, inclusive 2. Meet the case definition for severe malaria, per WHO standardized guidelines 3. Parent/guardian willing to provide informed consent 4. Assent for children between 8 and 14 years who are conscious and otherwise able to provide assent, inclusive Exclusion Criteria: 1\. Receipt of \> 24 hours of artemisinin therapy

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05750459). StuddyBuddy aggregates publicly available trial information.