RecruitingNot ApplicableNCT07287332

BLOOM: Pragmatic Feasibility Trial

Sponsor

Mayo Clinic

Enrollment

300 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Sepsis Infection

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria11

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

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Interventions

OTHERUp-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.

OTHERUsual 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.