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NCT Number: NCT07465432

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

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.

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Key information

Conditions

Drug Clearance After Severe Burn Injury Bacterial Infections Bacterial Infections and Mycoses Burns Gram-Negative Bacterial Infections Infections Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional One Health

Memphis, Tennessee, 38103, United States

Location status: Recruiting

Location contact

David Hill, Pharm.D., M.S.

CONTACT

[email protected]

901-545-8090

About this study

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

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefiderocol

Drug

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

Primary outcomes

  1. Appropriateness of package insert-stated dosing regimens

    Time frame: through study completion, an average of 3 days

    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.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • Center for Anti-Infective Research and Development
  • Regional Medical Center, Regional One Health
  • Shionogi Inc.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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