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BLOOM: Comparing Cefepime Dosing for Sepsis

This study, called BLOOM, is looking at two different ways to give cefepime, an antibiotic used for very sick patients with sepsis (a life-threatening response to infection). One way is the usual dose, and the other is a new method that uses more information about your body, like how well your kidneys are working, to choose the best dose. The main goal is to see how easy it is for doctors and nurses to use this new dosing method and how to best run this type of study. Researchers also want to see if the new method helps patients get better faster and has fewer side effects. You might be able to join if you are an adult (18 or older) in the ICU and are prescribed cefepime, unless you have a cephalosporin allergy or received cefepime recently before coming to the ICU. The study is currently recruiting up to 300 participants.

Study design
This study is comparing two groups: one receiving usual care and another receiving individualized dosing. It plans to enroll 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes for up to 1 year or until the sample size is reached.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07287332

BLOOM: Pragmatic Feasibility Trial

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~300 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Up-front individualized dosing algorithmUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients screened who qualified for the study
Measured over 1 year or once the sample size is achieved
+2 more outcomes measured

Conditions

Sepsis
Infection

Explore related trials

SepticemiaSeptic Shock

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Erin Barreto, PharmD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Gerald W. Flaby Jr., LRT, RRT
[email protected]
507-422-3462
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Proportion of patients screened who qualified for the study1 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

  • Distribution of qualified patients across care teams1 year or once the sample size is achieved

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

  • Adherence to dosing recommendations1 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