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.
This is a prospective, open-label, Phase 1b, pharmacokinetic study of Cefiderocol 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol
Hartford Hospital
Hartford, Connecticut, United States
Columbia University/New York Presbyterian Hospital
New York, New York, United States
Cefiderocol Clearance
The Clearance in liters/hour of Cefiderocol from the plasma of critically ill patients receiving ECMO.
Time frame: 8 hours
Cefiderocol Area Under the Curve (AUC)
The AUC in milligram\*hour/liter of Cefiderocol calculated from concentrations collected between zero and 8 hours at steady-state.
Time frame: 8 hours
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