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Rezafungin Pharmacokinetics in Patients on ECMO

NCT06329518 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-12-17

No results posted yet for this study

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

Interventions

DRUG

Rezafungin

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

Sponsors & Collaborators

  • Melinta Therapeutics, LLC

    collaborator INDUSTRY

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Joseph L. Kuti, PharmD · Hartford Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-12-11
Completion
2024-12-11
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06329518 on ClinicalTrials.gov