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Recruiting Phase 4 NCT07465432

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Trial Parameters

Condition Drug Clearance After Severe Burn Injury
Sponsor University of Tennessee
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2026-02-16
Completion 2027-02-28
Interventions
Cefiderocol

Brief 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 Criteria

Inclusion Criteria: * age ≥ 18 and ≤ 80 years old * estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation Exclusion Criteria: * KDIGO classification ≥ 1 at day of screening * known HIV or HBV infection

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