Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

Last updated: December 13, 2024
Sponsor: Hartford Hospital
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Cefiderocol

Clinical Study ID

NCT05373615
HHC-2022-0045
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or older;

  2. Receiving CRRT including CVVH, CVVHD, and CVVHDF support.

Exclusion

Exclusion Criteria:

  1. Females who are pregnant or breast-feeding;

  2. History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed byuneventful re-exposure is not a contraindication);

  3. A hemoglobin less than 8 gm/dl at baseline;

  4. Acute liver injury, defined as aspartate aminotransferase (AST) or alanineaminotransferase (ALT) > 5 times the upper limit of normal, or AST or ALT > 3 timesthe upper limit of normal with an associated total bilirubin > 2 times upper limitof normal;

  5. Any rapidly-progressing disease or immediately life-threatening illness (defined asimminent death within 48 hours in the opinion of the investigator);

  6. Any condition or circumstance that, in the opinion of the investigator, wouldcompromise the safety of the patient or the quality of study data.

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: Cefiderocol
Phase: 1
Study Start date:
July 25, 2022
Estimated Completion Date:
November 20, 2024

Study 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.

Connect with a study center

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

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