A Phase 4 interventional study of Cefiderocol in Drug Clearance After Severe Burn Injury, sponsored by University of Tennessee. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by University of Tennessee · Phase 4, Interventional, and Treatment
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.
Twelve patients with burn injuries will be enrolled after written consent is obtained. Six interval-specific samples will be drawn from each patient, depending on the dosing regimen chosen.
Inclusion Criteria: 1) age ≥ 18 and ≤ 80 years old, 2) estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation Exclusion Criteria
1) KDIGO classification ≥ 1 at day of screening, 2) known HIV or HBV infection Non-compartmental modeling via WinNonlin and Monte Carlo simulation will be used to determine the probability of cefiderocol dosing regimens achieving the fT>MIC threshold for P.aeruginosa. Safety monitoring for adverse events will occur daily up to and through the sampling period.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receiving cefiderocol
Drug: Cefiderocol
Cefiderocol will be prescribed according to indication and estimated renal function as either 2g over 3 hours dosed either every 6 or 8 hours.
Appropriateness of package insert-stated dosing regimens
Steady state blood samples will be collected and analyzed to establish concentration time profiles. Models will be established using body size, renal function, and severity of injury. Dosing regimens will be constructed and tested via Monte Carlo simulation to determine the probability of cefiderocol regimen achieving the fT\>MIC threshold for P.aeruginosa at 75% and 100% fT\>MIC.
Time frame: through study completion, an average of 3 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Tennessee