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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | University of Tennessee Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Status | Recruiting |
| Started | February 16, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT07465432 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.