BLOOM: Pragmatic Feasibility Trial

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07287332
Status
Recruiting
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Conditions

  • Infection
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Proportion of patients screened who qualified for the study [ Time Frame: 1 year or once the sample size is achieved ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Gerald W. Flaby Jr., LRT, RRT
[email protected]
507-422-3462

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