Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

NCT05373615 | Completed Phase 1 FDA Drug

• 1 other identifier: HHC-2022-0045
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Cefiderocol concentration

  The total and free plasma concentration of cefiderocol over time

  8 to 12 hours

• Cefiderocol clearance

  The Clearance in liters/hour of Cefiderocol from the plasma

  8 to 12 hours

• Cefiderocol maximum concentration

  The maximum concentration of Cefiderocol from the plasma

  8 to 12 hours

Study Arms (1)

Cefiderocol

EXPERIMENTAL

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

Drug: Cefiderocol

Interventions

Cefiderocol DRUG

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

Cefiderocol

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartford Hospital: lead
• Shionogi Inc.: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Interventions

Cefiderocol

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Clinical and Translational Infectious Diseases Research

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 13, 2022
• Study Start: July 25, 2022
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)