Rezafungin Pharmacokinetics in Patients on ECMO

Phase 1

Withdrawn

• Conditions: Sepsis
• Interventions: Drug: Rezafungin

• Registration Number: NCT06329518
• Lead Sponsor: Hartford Hospital

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Study Start: 2024-07-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-11
• Study Completion: 2024-12-11
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rezafungin	Rezafungin	Participants will receive one dose of rezafungin as per current prescribing information.

Primary Outcome Measures

Name	Time	Method
Rezafungin Clearance	168 hours	The Clearance in liters/hour of Rezafungin from the plasma of critically ill patients receiving ECMO

Secondary Outcome Measures

Name	Time	Method
Rezafungin Area Under the Curve (AUC)	168 hours	The AUC in milligram\*hour/liter of Rezafungin calculated from concentrations collected between zero and 168 hours at steady-state.

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States