Recruiting

Cefiderocol

Sponsor:

University of Tennessee

Code:

NCT07465432

Conditions

Drug Clearance After Severe Burn Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cefiderocol

Study Details

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.

Conditions

Drug Clearance After Severe Burn Injury

Study ID

NCT07465432

Start date

Feb 16, 2026

Status verified date

Mar, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cefiderocol

Patients receiving cefiderocol

Interventions

Cefiderocol

Cefiderocol will be prescribed according to indication and estimated renal function as either 2g over 3 hours dosed either every 6 or 8 hours.

Primary outcome measure

  • Appropriateness of package insert-stated dosing regimens [ Time Frame: through study completion, an average of 3 days ]

Central Contacts and Locations

Locations

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

David Hill, Pharm.D., M.S.

901-545-8090dhill19@uthsc.edu

More Information

Sponsor

University of Tennessee

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • burns
  • cefiderocol
  • pharmacokinetics
  • pharmacodynamics
  • augmented renal clearance
  • Gram-negative bacterial infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2026-03-12.