Clincosm LogoSign in Get a demo

Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

Sponsor
Hartford Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05373615
Collaborator
Shionogi Inc. (Industry)
16
Enrollment
1
Location
1
Arm
10.2
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Continuous Renal Replacement Therapy and Residual Renal Clearance on Cefiderocol Pharmacokinetics in Critically Ill Adult Patients
Actual Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cefiderocol

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

Outcome Measures

Primary Outcome Measures

  1. Cefiderocol concentration [8 to 12 hours]

    The total and free plasma concentration of cefiderocol over time

  2. Cefiderocol clearance [8 to 12 hours]

    The Clearance in liters/hour of Cefiderocol from the plasma

  3. Cefiderocol maximum concentration [8 to 12 hours]

    The maximum concentration of Cefiderocol from the plasma

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age 18 years or older;

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

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 by uneventful 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 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;

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hartford Hospital Hartford Connecticut United States 06102

Sponsors and Collaborators

  • Hartford Hospital
  • Shionogi Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tomefa Asempa, Associate Director, Clinical and Translational Infectious Diseases Research, Hartford Hospital
ClinicalTrials.gov Identifier:
NCT05373615
Other Study ID Numbers:
  • HHC-2022-0045
First Posted:
May 13, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 3, 2022