Cefiderocol PK in Patients on ECMO
NCT04995835 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2024-12-16
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 antibiotic, Cefiderocol, in critically ill patient receiving ECMO.
Conditions
Interventions
- DRUG
-
Cefiderocol
After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol
Sponsors & Collaborators
-
Shionogi Inc.
collaborator INDUSTRY -
Joseph L. Kuti, PharmD
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
- 2021-07-16
- Primary Completion
- 2024-06-01
- Completion
- 2024-09-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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