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Recruiting NCT07287332

BLOOM: Pragmatic Feasibility Trial

No phase Interventional Sepsis Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Up-front individualized dosing algorithm, Usual Care.
Who it may be relevant to
Registry conditions: Sepsis, Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Number of antibiotic-free days [Time frame: 28-days]
  • ICU length of stay [Time frame: 1 year]
  • Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance [Time frame: 6 months]
  • Proportion of patients who experience clinical success [Time frame: 8 days]
  • Proportion of patients who experience microbiologic success [Time frame: 8 days]
  • Mortality [Time frame: 28-days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

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. PMID 40013864

Identifiers

NCT: NCT07287332 · 25-004564

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗