RECRUITING

Rezafungin Pharmacokinetics in Patients on ECMO

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-07-01
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06329518

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Receiving venovenous or venoarterial ECMO support.
  1. * Females who are pregnant or breast-feeding
  2. * History of any moderate or severe hypersensitivity or allergic reaction to any echinocandin antifungal
  3. * Receiving rezafungin to treat documented or suspected infection within 14 days of screening, or expected to receive rezafungin during the study intervention phase
  4. * Receiving or likely to require intermittent hemodialysis
  5. * A hemoglobin less than 7.2 gm/dl at baseline
  6. * 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
  7. * Patients expected to have ECMO discontinued within the next 24 hours
  8. * Any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
  9. * Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data

Contacts and Locations

Study Contact

Joseph L. Kuti, PharmD
CONTACT
860-972-3612
joseph.kuti@hhchealth.org
Keelyn Kotecki
CONTACT
860-972-3004
keelyn.kotecki@hhchealth.org

Principal Investigator

Joseph L. Kuti, PharmD
PRINCIPAL_INVESTIGATOR
Hartford Hospital

Study Locations (Sites)

Hartford Hospital
Hartford, Connecticut, 06102
United States

Collaborators and Investigators

Sponsor: Hartford Hospital

  • Joseph L. Kuti, PharmD, PRINCIPAL_INVESTIGATOR, Hartford Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2025-04

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • pharmacokinetics
  • echinocandins

Additional Relevant MeSH Terms

  • Sepsis