Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
Recruiting
Phase 4
Interventional Study
Drug Clearance After Severe Burn Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- University of Tennessee · Other
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About This Trial
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 pharmaco…
Trial Locations
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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
Contacts
No contact information available.