Optimizing cefiderocol dosing after acute burn injury
Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
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 |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Tennessee Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT07465432 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Memphis, Tennessee
- Regional One Health — Memphis, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.