BLOOM: Pragmatic Feasibility Trial

NCT07287332 | Recruiting

• 1 other identifier: 25-004564
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Number of antibiotic-free days

  28-days

• ICU length of stay

  1 year

• Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance

  6 months

• Proportion of patients who experience clinical success

  8 days

• Proportion of patients who experience microbiologic success

  8 days

Study Arms (2)

Up-front individualized dosing algorithm

EXPERIMENTAL

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

Other: Up-front individualized dosing algorithm

Usual Care

ACTIVE COMPARATOR

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

Interventions

Up-front individualized dosing algorithm OTHER

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.

Up-front individualized dosing algorithm

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40013864 BACKGROUND

MeSH Terms

Conditions

Sepsis; Infections; Shock, Septic; Communicable Diseases

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• Erin Barreto, PharmD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald W. Flaby Jr., LRT, RRT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)