Drug Clearance After Severe Burn InjuryPhase 4NCT07465432
Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
A Phase 4 study testing Cefiderocol in people with Drug Clearance After Severe Burn Injury, run by University of Tennessee at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Clearance After Severe Burn Injury
- What is being tested?
- Cefiderocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 28 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 and ≤ 80 years old
- estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation
Who cannot join
- KDIGO classification ≥ 1 at day of screening
- known HIV or HBV infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Regional One Health
Memphis, Tennessee, 38103
David Hill, Pharm.D., M.S., 901-545-8090, dhill19@uthsc.edu
About this study
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.
Read the detailed description
Twelve patients with burn injuries will be enrolled after written consent is obtained. Six interval-specific samples will be drawn from each patient, depending on the dosing regimen chosen.
Inclusion Criteria: 1) age ≥ 18 and ≤ 80 years old, 2) estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation Exclusion Criteria
- KDIGO classification ≥ 1 at day of screening, 2) known HIV or HBV infection Non-compartmental modeling via WinNonlin and Monte Carlo simulation will be used to determine the probability of cefiderocol dosing regimens achieving the fT>MIC threshold for P.aeruginosa. Safety monitoring for adverse events will occur daily up to and through the sampling period.
- Conditions
- Drug Clearance After Severe Burn Injury
- Being tested
- Cefiderocol
- Keywords
- burns, cefiderocol, pharmacokinetics, pharmacodynamics, augmented renal clearance, Gram-negative bacterial infections
- Medical subject headings
- Burns, Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefiderocolDrug
Cefiderocol will be prescribed according to indication and estimated renal function as either 2g over 3 hours dosed either every 6 or 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Cefiderocol | Experimental | Patients receiving cefiderocol Receives: Drug: Cefiderocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start16 Feb 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Clearance After Severe Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Shionogi Inc., Regional Medical Center, Regional One Health, Center for Anti-Infective Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465432
- Sponsor's protocol ID
- 24-10202-FB
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
- ClinicalTrials.gov ID
- NCT07465432
- Acronym / sponsor ID
- 24-10202-FB
- Conditions
- Drug Clearance After Severe Burn Injury
- Keywords
- burns, cefiderocol, pharmacokinetics, pharmacodynamics, augmented renal clearance, Gram-negative bacterial infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Shionogi Inc., Regional Medical Center, Regional One Health, Center for Anti-Infective Research and Development
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Twelve patients with burn injuries will be enrolled after written consent is obtained. Six interval-specific samples will be drawn from each patient, depending on the dosing regimen chosen.
Inclusion Criteria: 1) age ≥ 18 and ≤ 80 years old, 2) estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation Exclusion Criteria
- KDIGO classification ≥ 1 at day of screening, 2) known HIV or HBV infection Non-compartmental modeling via WinNonlin and Monte Carlo simulation will be used to determine the probability of cefiderocol dosing regimens achieving the fT>MIC threshold for P.aeruginosa. Safety monitoring for adverse events will occur daily up to and through the sampling period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Cefiderocol | Experimental | Drug: CefiderocolPatients receiving cefiderocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 and ≤ 80 years old
- estimated CLCR (eCLCR) ≥ 60 mL/min via Cockcroft-Gault equation
Key exclusion criteria (2 listed)
- KDIGO classification ≥ 1 at day of screening
- known HIV or HBV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefiderocolCefiderocol will be prescribed according to indication and estimated renal function as either 2g over 3 hours dosed either every 6 or 8 hours. | Drug | Cefiderocol |
Primary outcome
Appropriateness of package insert-stated dosing regimens
Time frame: through study completion, an average of 3 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefiderocol in people with Drug Clearance After Severe Burn Injury, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriateness of package insert-stated dosing regimens (time frame: through study completion, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.