Rezafungin Pharmacokinetics in Patients on ECMO

Description

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

Conditions

Sepsis

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Study Overview

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Study Details

Study overview

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

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

Rezafungin Pharmacokinetics in Patients on ECMO

Condition
Sepsis
Intervention / Treatment

-

Contacts and Locations

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18 years or older
  • * Receiving venovenous or venoarterial ECMO support.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hartford Hospital,

Joseph L. Kuti, PharmD, PRINCIPAL_INVESTIGATOR, Hartford Hospital

Study Record Dates

2025-04