Recruiting

Cefepime

Sponsor:

Mayo Clinic

Code:

NCT07287332

Conditions

Sepsis

Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Up-front individualized dosing algorithm

Usual Care

Study Details

Brief summary:

The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about the patient's body including their kidney function. The primary purpose of this study is to test how easy it is for healthcare professionals to use the new dosing method and how best to conduct the trial. The study will also assess if the new dosing method helps patients recover faster and reduces side effects.

Conditions

Sepsis

Infection

Study ID

NCT07287332

Start date

Jan 15, 2026

Status verified date

Feb, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults ≥18 years of age
  • Admitted to one of the ICUs at the study center
  • Prescribed cefepime therapy by the care team

Exclusion Criteria:

  • Individuals will be those with a cephalosporin allergy
  • Received >1 dose of cefepime in the 24 hours before ICU admission
  • Transferred from an external hospital without compatible EHR
  • Does not have a cystatin C and a creatinine available for drug dosing
  • Acute kidney injury stage 2 or higher
  • Receiving renal replacement therapy
  • Treated with extracorporeal membrane oxygenation
  • Undergoing molecular adsorbent recirculating therapy at the time of beta-lactam initiation
  • Pregnant
  • Incarcerated
  • Declined Minnesota research authorization

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Up-front individualized dosing algorithm

Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight.

active comparator: Usual Care

The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr.

Interventions

Up-front individualized dosing algorithm

An individualized cefepime dosing algorithm will be used to determine the cefepime dose and interval. The dose recommendation will be provided using the EHR-prompts to the clinical care team and ordered and/or verified by the ICU pharmacist using an established collaborative practice agreement. As a pragmatic trial, at any point care teams may modify the empiric or subsequent dose based on their clinical judgement.

Usual Care

The standard of care group will receive empiric dosing guided by an institutional antimicrobial guide. Cefepime is typically dosed at 0.5-2 g every 8-24 h according to categorical thresholds of estimated creatinine clearance (eGFRcr). Cystatin C and eGFRcr-cys can be calculated and used at clinicians' discretion to aid in drug dose determination.

Primary outcome measure

  • Proportion of patients screened who qualified for the study [ Time Frame: 1 year or once the sample size is achieved ]
  • Distribution of qualified patients across care teams [ Time Frame: 1 year or once the sample size is achieved ]
  • Adherence to dosing recommendations [ Time Frame: 1 year or once the sample size is achieved ]

Central Contacts and Locations

Central contacts

Gerald W. Flaby Jr., LRT, RRT

507-422-3462flaby.gerald@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Gerald W. Flaby Jr., LRT, RRT

507-422-3462flaby.gerald@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Beta-lactam antibiotics
  • Sepsis
  • Septic shock
  • Pharmacokinetics
  • Personalized medicine
  • Therapeutic drug monitoring
  • Infectious disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-06.