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?

This trial tests how well the antibiotic cefiderocol works for people with burn injuries. Although cefiderocol treats certain infections, its effectiveness in patients with burns remains unknown. The study aims to determine the right dose and timing to effectively combat infections in these patients. This trial may suit those with burn injuries who do not have kidney problems or certain viral infections. As a Phase 4 trial, cefiderocol has already received FDA approval and proven effective. This research seeks to understand its benefits for more patients, offering a chance to contribute to medical knowledge while receiving a trusted treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that cefiderocol is generally safe for patients with burn injuries. In one study, patients with burns treated with cefiderocol experienced good results without serious side effects, suggesting its safety for treating infections in these patients. Another study found no serious side effects, although it noted deaths due to infection, highlighting the severity of these infections rather than a problem with the drug itself.

Cefiderocol is already approved for treating serious infections like pneumonia and urinary tract infections, supporting its safety profile. Its ability to combat tough, drug-resistant bacteria makes it a promising choice for individuals with severe burns. Overall, current evidence suggests that cefiderocol is a safe and effective option for treating infections in burn patients.12345

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for burn injuries, which often rely on topical antibiotics and wound care, cefiderocol is a cutting-edge antibiotic that works by using a novel mechanism called siderophore cephalosporin. This allows the drug to hijack the bacteria's iron uptake process, penetrating and killing even highly resistant bacteria. Researchers are excited because cefiderocol could provide a powerful new option against infections in burn patients, especially where traditional antibiotics may fail.

What is the effectiveness track record for cefiderocol in treating burn injuries?

Research has shown that cefiderocol is a strong antibiotic effective against difficult infections caused by certain bacteria. Studies have found it effective in treating complex urinary tract infections and hospital-acquired pneumonia. In very sick patients with hard-to-treat infections, cefiderocol achieved a success rate of 84.3%. Its unique mechanism allows it to combat bacteria that other drugs cannot, making it a good choice for resistant infections. This trial will evaluate cefiderocol in patients with burn injuries. Although it has not been tested in this specific context yet, its proven ability to tackle severe infections suggests it might work well in this situation too.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 who have deep partial thickness burns and a good kidney function (creatinine clearance of at least 60 mL/min).

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

Trial Overview

The study is testing how the antibiotic cefiderocol behaves in the body (absorption, distribution, breakdown) in patients with serious burn injuries. The goal is to find the best dose and timing for this group.

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

Citations

Cefiderocol

Cefiderocol, sold under the brand name Fetroja (by Shionogi) among others, is an antibiotic used to treat complicated urinary tract infections

2.

fetroja.com

fetroja.com/

Fetroja® (cefiderocol) | Official HCP Site

Learn about Fetroja, a cephalosporin antibacterial for the treatment of cUTI and HABP/VABP infections caused by certain susceptible Gram-negative ...

Cefiderocol, a new antibiotic against multidrug-resistant Gram ...

Cefiderocol is approved for the treatment of complicated urinary tract infections, hospital-acquired bacterial pneumonia and ventilator-associated bacterial ...

Cefiderocol (intravenous route) - Side effects & uses

Cefiderocol injection is used to treat complicated urinary tract infection (including pyelonephritis) in patients who have limited or no other treatment ...

Cefiderocol – An effective antimicrobial for MDR infections ...

Cefiderocol is a novel cephalosporin–siderophore conjugate antibiotic that holds promise to thwart infections caused by multi-drug-resistant gram-negative ...

Use of Cefiderocol in Management of Resistant Gram ... - PMC

This is the first study detailing the clinical course and outcomes associated with cefiderocol use in a burn center. Patients with complex ...

650. Cefiderocol use in burn patients admitted to an intensive ...

The median burn size was 47% TBSA (IQR 31, 60 days). The median time from injury to cefiderocol initiation was 73.5 days (IQR 49.5, 108).

Outcomes in patients with thermal injury treated ...

Ages ranged from 7 to 64 years old, with burn size 8–97.9 % total body surface area. Six patients had flame burn injuries while one had an electrical injury.

Real-Life Data on the Effectiveness and Safety of Cefiderocol ...

Overall, 30-day and 90-day mortality rates were 10% and 50%, respectively, although two out of five patients died due to the infection. No serious adverse ...

Pharmacokinetic Analysis of Cefiderocol in Patients With ...

The primary objective of this study is to evaluate the pharmacokinetic principles of cefiderocol in patients after acute burn injury. Findings from this study ...