Rezafungin PK in Patients on ECMO

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329518
• Other study ID #: HHC-2024-0064
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Hartford Hospital
• Contact: Joseph L. Kuti, PharmD
• Phone: 860-972-3612
• Email: joseph.kuti[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a prospective, open-label, Phase 1b, pharmacokinetic study of Rezafunginin 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

Drug:
• Rezafungin
After receipt of Rezafungin, blood samples will be collected at various time points to determine the pharmacokinetics of Rezafungin.

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Melinta Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rezafungin Clearance	The Clearance in liters/hour of Rezafungin from the plasma of critically ill patients receiving ECMO	168 hours
Secondary	Rezafungin Area Under the Curve (AUC)	The AUC in milligram*hour/liter of Rezafungin calculated from concentrations collected between zero and 168 hours at steady-state.	168 hours