Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

NCT07465432 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-10202-FB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Appropriateness of package insert-stated dosing regimens

  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.

  through study completion, an average of 3 days

Study Arms (1)

Cefiderocol

EXPERIMENTAL

Patients receiving cefiderocol

Drug: Cefiderocol

Interventions

Cefiderocol DRUG

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

Cefiderocol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 and ≤ 80 years old
• estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation

You may not qualify if:

• KDIGO classification ≥ 1 at day of screening
• known HIV or HBV infection

Sponsors & Collaborators

• University of Tennessee: lead
• Shionogi Inc.: collaborator
• Regional Medical Center, Regional One Health: collaborator
• Center for Anti-Infective Research and Development: collaborator

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38103, United States

RECRUITING

MeSH Terms

Conditions

Burns; Gram-Negative Bacterial Infections

Interventions

Cefiderocol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 12, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)