Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 80

Optimizing cefiderocol dosing after acute burn injury

Official title: Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Run by University of Tennessee · NCT07465432 · Data updated 2026-11-12

This study tests whether usual cefiderocol doses keep antibiotic levels high enough to treat infections in adults with acute burn injuries.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment12 (estimated)
SponsorUniversity of Tennessee
Academic / other
Locations1 site (Memphis, Tennessee)
StatusRecruiting
StartedFebruary 16, 2026
Main results expectedFebruary 28, 2027
Study endsFebruary 28, 2027
Registry record updatedMarch 12, 2026
Trial IDNCT07465432 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–80 with acute burn injuries, estimated creatinine clearance ≥60 mL/min, no acute kidney injury (KDIGO <1), and no known HIV or HBV infection who can be treated at the Memphis site are ideal candidates.

Probably not a fit

Patients with reduced kidney function (KDIGO ≥1), known HIV or HBV infection, children, or those unable to attend the Memphis site are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adult patients (18–80 years) with acute burn injuries and estimated creatinine clearance ≥60 mL/min will be enrolled at a single center. Each participant will receive cefiderocol per the chosen dosing regimen and six timed blood samples will be taken to measure drug concentrations. Noncompartmental pharmacokinetic analysis and Monte Carlo simulation will be used to model drug exposure and the probability of achieving the free time-above-MIC (fT>MIC) target for Pseudomonas aeruginosa. Daily safety monitoring will occur during the sampling period and patients with KDIGO ≥1 or known HIV/HBV infection are excluded.

Why it matters

Potential benefit: If successful, the study could identify dosing and interval adjustments that ensure bactericidal cefiderocol concentrations in burn patients, improving treatment and limiting resistance.

How similar studies have gone: Cefiderocol has established dosing data for pneumonia and urinary tract infections and dosing for augmented renal clearance has been explored, but pharmacokinetics in acute burn patients remain largely unstudied.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Regional One Health
    Memphis, Tennessee, United States
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.