A Phase 1 interventional study of Cefiderocol in Pharmacokinetics, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Hartford Hospital · Phase 1, Interventional, and Basic science
Continuous renal replacement therapies (CRRT) such as continuous venovenous hemofiltration are used to provide renal support for critically ill patients with acute kidney injury (AKI), particularly patients who are hemodynamically unstable. 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 CRRT 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 CRRT.
This is a prospective, multi-center, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 16 critically ill patients receiving CRRT support. 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 standard of care antibiotics which may include cefiderocol as necessary to treat any current infection.
Hartford Hospital is the lead sponsor of 104 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.
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Exclusion Criteria:
Participants will receive four to six doses of Cefiderocol as per current prescribing information based on effluent rate
Drug: Cefiderocol
After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol
Cefiderocol concentration
The total and free plasma concentration of cefiderocol over time
Time frame: 8 to 12 hours
Cefiderocol clearance
The Clearance in liters/hour of Cefiderocol from the plasma
Time frame: 8 to 12 hours
Cefiderocol maximum concentration
The maximum concentration of Cefiderocol from the plasma
Time frame: 8 to 12 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Nov 2024, 27 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cefiderocol