Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Tennessee

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

12 Participants
are divided into 1 treatment group

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