12 Participants NeededMy employer runs this trial

Cefiderocol for Burn Injuries

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Tennessee
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 80 years old.
* estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Patients receive cefiderocol and undergo pharmacokinetic sampling

3 days
Daily visits for sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Cefiderocol

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CefiderocolExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials
202
Recruited
146,000+

Shionogi Inc.

Industry Sponsor

Trials
10
Recruited
760+

Regional Medical Center, Regional One Health

Collaborator

Trials
1
Recruited
1+

Center for Anti-Infective Research and Development

Collaborator