Cefiderocol Dosing in Patients with Acute Burn Injuries

This study is looking at how the antibiotic cefiderocol moves through the bodies of patients who have recently experienced severe burn injuries. Cefiderocol is a powerful medicine used to treat serious infections. We want to understand if the usual doses of cefiderocol work effectively in burn patients, who can process medicines differently. The study will help determine the best dose and schedule for cefiderocol in this group to fight infections and prevent antibiotic resistance. You may be able to join if you are between 18 and 80 years old and have good kidney function. The study is currently unclear on its recruitment status and aims to enroll 12 patients.

Study design
This is an interventional study with 12 participants. It is a single-arm study, meaning all participants will receive the same treatment.
What's involved
You would receive cefiderocol as part of your treatment. Six blood samples would be drawn from you, depending on your dosing schedule.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored daily up to and through the sampling period, which averages 3 days.

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NCT07465432

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Recruiting
PHASE4Ages 18–80InterventionalTreatment
University of Tennessee
~12 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Cefiderocol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Appropriateness of package insert-stated dosing regimens
Measured over through study completion, an average of 3 days
Drug Clearance After Severe Burn Injury
1 sites across 1 states
Tennessee1

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Eligibility criteria

Inclusion

age ≥ 18 and ≤ 80 years old
estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation

Exclusion

KDIGO classification ≥ 1 at day of screening
known HIV or HBV infection
  • Appropriateness of package insert-stated dosing regimensthrough 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.