Pharmacokinetics and Ex Vivo Sequestration of Rezafungin in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

HHC-2024-0064

Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum echinocandin, Rezafungin, in critically ill patients receiving ECMO

2024-04-01

2025-04-01

2025-04-01

Not yet recruiting

Early phase I

8

Inclusion Criteria: * Age 18 years or older * Receiving venovenous or venoarterial ECMO support. Exclusion Criteria: * Females who are pregnant or breast-feeding * History of any moderate or severe hypersensitivity or allergic reaction to any echinocandin antifungal * Receiving rezafungin to treat documented or suspected infection within 14 days of screening, or expected to receive rezafungin during the study intervention phase * Severe renal dysfunction defined as a CrCL \< 15 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis * A hemoglobin less than 7.2 gm/dl at baseline * Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal * Patients expected to have ECMO discontinued within the next 24 hours * Any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator) * Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}

2024-03-26