About this trial
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.
Eligibility criteria
Qualifiers
age ≥ 18 and ≤ 80 years old
estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation
Disqualifiers
KDIGO classification ≥ 1 at day of screening
known HIV or HBV infection
Trial design
Treatments tested in this trial
- Cefiderocol
Treatment groups
Sponsors and collaborators
University of Tennessee
Lead sponsor
Shionogi Inc.
Collaborator
Regional Medical Center, Regional One Health
Collaborator
Center for Anti-Infective Research and Development
Collaborator