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NCT Number: NCT07287332

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.

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Key information

Conditions

Sepsis Communicable Diseases Disease Attributes Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Gerald W. Flaby Jr., LRT, RRT

CONTACT

[email protected]

507-422-3462

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients screened who qualified for the study

    Time frame: 1 year or once the sample size is achieved

    Number of patients who quality for the study out of total number of patients screened, reported as a percentage

  2. Distribution of qualified patients across care teams

    Time frame: 1 year or once the sample size is achieved

    Number of patients from each ICU care team who qualify for the study

  3. Adherence to dosing recommendations

    Time frame: 1 year or once the sample size is achieved

    Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage

Secondary outcomes

  1. Number of antibiotic-free days

    Time frame: 28-days

    Number of antibiotic-free days for the first 28 days

  2. ICU length of stay

    Time frame: 1 year

    Number of days of initial ICU stay

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

    Time frame: 6 months

    New anti-Pseudomonal beta-lactam resistance which develops within the 6 months following initial treatment

  4. Proportion of patients who experience clinical success

    Time frame: 8 days

    Complete or partial resolution of clinical signs and symptoms attributed to infection across 8 days of therapy.

  5. Proportion of patients who experience microbiologic success

    Time frame: 8 days

    Presumed or documented eradication of causative microorganisms

  6. Mortality

    Time frame: 28-days

    All cause death

Study contacts

Contact information is provided by the study sponsor or research team.

Gerald W. Flaby Jr., LRT, RRT

CONTACT

[email protected]

507-422-3462

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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