Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Phase 4RecruitingNCT07465432

University of Tennessee12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug Clearance After Severe Burn Injury

Interventions

CefiderocolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Regional One Health

Memphis, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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