Rezafungin Pharmacokinetics in Patients on ECMO

NCT06329518 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: HHC-2024-0064
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sepsis

Keywords

pharmacokinetics; echinocandins

Outcome Measures

Primary Outcomes (1)

• Rezafungin Clearance

  The Clearance in liters/hour of Rezafungin from the plasma of critically ill patients receiving ECMO

  168 hours

Secondary Outcomes (1)

• Rezafungin Area Under the Curve (AUC)

  168 hours

Study Arms (1)

Rezafungin

EXPERIMENTAL

Participants will receive one dose of rezafungin as per current prescribing information.

Drug: Rezafungin

Interventions

Rezafungin DRUG

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

Also known as: rezafungin acetate

Rezafungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Melinta Therapeutics, LLC: collaborator

MeSH Terms

Conditions

Sepsis

Interventions

Rezafungin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph L. Kuti, PharmD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Anti-Infective Research and Development

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: July 1, 2024
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12