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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cefiderocol
DrugCefiderocol will be prescribed according to indication and estimated renal function as either 2g over 3 hours dosed either every 6 or 8 hours.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: CefiderocolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSponsors and contacts
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University of Tennessee
Lead sponsor
Shionogi Inc.
Collaborator
Regional Medical Center, Regional One Health
Collaborator
Center for Anti-Infective Research and Development
Collaborator
Source ClinicalTrials.gov