RecruitingPhase 4NCT07465432

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries


Sponsor

University of Tennessee

Enrollment

12 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • age ≥ 18 and ≤ 80 years old
  • estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation

Exclusion Criteria2

  • KDIGO classification ≥ 1 at day of screening
  • known HIV or HBV infection

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Interventions

DRUGCefiderocol

Cefiderocol will be prescribed according to indication and estimated renal function as either 2g over 3 hours dosed either every 6 or 8 hours.


Locations(1)

Regional One Health

Memphis, Tennessee, United States

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NCT07465432