Status:
COMPLETED
Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
Shionogi Inc.
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
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 pa...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age 18 years or older;
- Receiving CRRT including CVVH, CVVHD, and CVVHDF support.
Exclusion
- Females who are pregnant or breast-feeding;
- History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication);
- A hemoglobin less than 8 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;
- 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.
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05373615
Start Date
July 25 2022
End Date
November 20 2024
Last Update
December 18 2024
Active Locations (1)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102