Rezafungin Pharmacokinetics in Patients on ECMO

Hartford Hospital

Status and phase

Withdrawn

Phase 1

Conditions

Sepsis

Treatments

Drug: Rezafungin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06329518

HHC-2024-0064

Details and patient eligibility

About

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

Full description

This is a prospective, open-label, Phase 1b, pharmacokinetic study of Rezafungin in 8 critically ill patients receiving ECMO support at Hartford Hospital. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive other antibiotics as necessary to treat any current infection.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Receiving or likely to require intermittent 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