Pharmacokinetics
Conditions
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.
Interventions
DRUGCefiderocol
After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol
Sponsors
Shionogi Inc.
Hartford Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cefiderocol concentration | 8 to 12 hours | The total and free plasma concentration of cefiderocol over time |
| Cefiderocol clearance | 8 to 12 hours | The Clearance in liters/hour of Cefiderocol from the plasma |
| Cefiderocol maximum concentration | 8 to 12 hours | The maximum concentration of Cefiderocol from the plasma |
Countries
United States
Outcome results
None listed