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NCT07465432 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
A Phase 4 study of Drug Clearance After Severe Burn Injury, sponsored by University of Tennessee.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07465432: Recruiting Phase 4 study of Drug Clearance After Severe Burn Injury, sponsored by University of Tennessee.
NCT07465432 is a Phase 4 study of Drug Clearance After Severe Burn Injury that is actively recruiting participants, run by University of Tennessee. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07465432, a Phase 4 study of Drug Clearance After Severe Burn Injury, is actively recruiting participants, sponsored by University of Tennessee.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Cefiderocol
Study Locations (1)
Tennessee
- Regional One Health - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-02-16 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 4 |
What NCT07465432 shows while recruiting
NCT07465432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Drug Clearance After Severe Burn Injury appearing as the primary indexed condition, and to 1 intervention - of which Cefiderocol is the first listed.
NCT07465432 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT07465432 about?
NCT07465432 is a clinical study titled "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 popula...
What is the current status of trial NCT07465432?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2026-02-16. Estimated completion is 2027-02-28.
What conditions does trial NCT07465432 study?
This clinical trial studies the following conditions: Drug Clearance After Severe Burn Injury.
What interventions are being tested in trial NCT07465432?
The interventions under investigation include: Cefiderocol (DRUG).
Who is sponsoring clinical trial NCT07465432?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07465432 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07465432's enrollment target sits among peer trials
12 1914th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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