Actively Recruiting
Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
Led by University of Tennessee · Updated on 2026-03-12
12
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
Sponsors
U
University of Tennessee
Lead Sponsor
S
Shionogi Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cefiderocol is a powerful, broad spectrum antibiotic approved to treat hospital-acquired or ventilator associated pneumonia and urinary tract infections. Although cefiderocol has labeled dosing recommendations, including augmented renal clearance, patients with burn injury remain an unstudied population at high risk for MDR pathogens. The primary objective of this study is to evaluate the pharmacokinetic principles of cefiderocol in patients after acute burn injury. Findings from this study will determine the dose and interval necessary to maintain therapeutic concentrations of cefiderocol in patients after burn injury for adequate bactericidal activity, prevention of resistance, and treatment outcomes.
CONDITIONS
Official Title
Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Estimated creatinine clearance (eCLCR) of 60 mL/min or higher using Cockcroft-Gault equation
You will not qualify if you...
- KDIGO classification of 1 or higher at day of screening
- Known infection with HIV or hepatitis B virus (HBV)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Regional One Health
Memphis, Tennessee, United States, 38103
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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