Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

Pharmacokinetics Clinical Trial

Official title:

Effect of Continuous Renal Replacement Therapy and Residual Renal Clearance on Cefiderocol Pharmacokinetics in Critically Ill Adult Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05373615
• Other study ID #: HHC-2022-0045
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 25, 2022
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Shionogi Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cefiderocol concentration	The total and free plasma concentration of cefiderocol over time	8 to 12 hours
Primary	Cefiderocol clearance	The Clearance in liters/hour of Cefiderocol from the plasma	8 to 12 hours
Primary	Cefiderocol maximum concentration	The maximum concentration of Cefiderocol from the plasma	8 to 12 hours