BLOOM: Pragmatic Feasibility Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Infection
• Intervention / Treatment: Other: Up-front individualized dosing algorithm; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerald W. Flaby Jr., LRT, RRT; Phone Number: 507-422-3462; Email: flaby.gerald@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Gerald W. Flaby Jr., LRT, RRT; Phone Number: 507-422-3462; Email: flaby.gerald@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Up-front individualized dosing algorithm; Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight.	Other: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients screened who qualified for the study	Number of patients who quality for the study out of total number of patients screened, reported as a percentage	1 year or once the sample size is achieved
Distribution of qualified patients across care teams	Number of patients from each ICU care team who qualify for the study	1 year or once the sample size is achieved
Adherence to dosing recommendations	Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage	1 year or once the sample size is achieved

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of antibiotic-free days	Number of antibiotic-free days for the first 28 days	28-days
ICU length of stay	Number of days of initial ICU stay	1 year
Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance	New anti-Pseudomonal beta-lactam resistance which develops within the 6 months following initial treatment	6 months
Proportion of patients who experience clinical success	Complete or partial resolution of clinical signs and symptoms attributed to infection across 8 days of therapy.	8 days
Proportion of patients who experience microbiologic success	Presumed or documented eradication of causative microorganisms	8 days
Mortality	All cause death	28-days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Erin Barreto, PharmD, PhD, Mayo Clinic

Publications and helpful links

General Publications

• Barreto EF, Scheetz MH, Chang J, Cole KC, Fogelson LA, Paul J, Jannetto PJ, Gajic O, Rule AD; Beta Lactam Optimization and Outcomes Management (BLOOM) Study Group. Cystatin C-Guided Dosing Nomogram Improves Target Attainment for Cefepime in the Critically Ill. Crit Care Med. 2025 Apr 1;53(4):e941-e952. doi: 10.1097/CCM.0000000000006622. Epub 2025 Feb 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Therapeutic drug monitoring; Septic shock; Sepsis; Personalized medicine; Beta-lactam antibiotics; Infectious disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Communicable Diseases; Shock, Septic
• Other Study ID Numbers: 25-004564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No