Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

  • STATUS
    Recruiting
  • End date
    Jun 29, 2023
  • participants needed
    16
  • sponsor
    Hartford Hospital
Updated on 4 October 2022

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 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.

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 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.

Details
Condition Pharmacokinetics
Treatment Cefiderocol
Clinical Study IdentifierNCT05373615
SponsorHartford Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Receiving CRRT including CVVH, CVVHD, and CVVHDF support

Exclusion Criteria

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
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