Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

NCT ID: NCT05373615

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2024-11-20

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.

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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cefiderocol

Participants will receive four to six doses of Cefiderocol as per current prescribing information based on effluent rate

Group Type: EXPERIMENTAL

Cefiderocol

Intervention Type: DRUG

After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol

Interventions

Cefiderocol

After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shionogi Inc.

INDUSTRY

Sponsor Role: collaborator

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tomefa Asempa

Associate Director, Clinical and Translational Infectious Diseases Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

HHC-2022-0045

Identifier Type: -

Identifier Source: org_study_id