NCT07465432 Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
| NCT ID | NCT07465432 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Tennessee |
| Condition | Drug Clearance After Severe Burn Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 12 participants in total. It began in 2026-02-16 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07465432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Drug Clearance After Severe Burn Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07465432 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07465432 currently recruiting?
Yes, NCT07465432 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Tennessee to inquire about joining.
Where is the NCT07465432 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT07465432 clinical trial?
NCT07465432 is sponsored by University of Tennessee. The trial plans to enroll 12 participants.