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Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07465432
Lead Sponsor University of Tennessee
Collaborators: Shionogi Inc., Regional Medical Center, Regional One Health, Center for Anti-Infective Research and Development
Conditions
(from sponsor)		 Drug Clearance After Severe Burn Injury
Related terms Burns, Gram-Negative Bacterial Infections
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov