BLOOM: Personalized cefepime dosing for adults in the ICU
Official title: BLOOM: Pragmatic Feasibility Trial
Run by Mayo Clinic · NCT07287332 · Data updated 2026-11-12
This trial tests whether using an individualized way to pick cefepime doses based on a patient’s kidney tests helps ICU patients recover faster and have fewer side effects compared with usual dosing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | March 2027 |
| Study ends | July 2027 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT07287332 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) admitted to a study ICU who are newly prescribed cefepime and have both creatinine and cystatin C available for dosing decisions are ideal candidates.
✕Probably not a fit
Patients with a cephalosporin allergy, significant acute kidney injury (stage 2 or higher), on renal replacement therapy or ECMO, pregnant, incarcerated, or lacking compatible records are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic, interventional feasibility trial compares an up-front individualized dosing algorithm for cefepime to usual care in adult ICU patients who are prescribed the antibiotic. The dosing algorithm uses routinely available doses but selects among them based on additional patient information, including creatinine and cystatin C, to better match antibiotic exposure to kidney function. The primary aim is to test how easy the new dosing method is for clinical teams to use and to refine trial procedures for a larger study, with secondary outcomes looking at speed of recovery and antibiotic-related adverse events. The trial is single-center and enrolls patients admitted to ICUs at Mayo Clinic in Rochester, Minnesota.
Why it matters
Potential benefit: If successful, the approach could lead to more appropriate cefepime dosing that speeds recovery and reduces drug-related side effects for critically ill patients.
How similar studies have gone: Personalized beta-lactam dosing and therapeutic drug monitoring have shown promise in other research, but using a pragmatic, up-front algorithm based on cystatin C in routine ICU care is a more novel, less-tested approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Erin Barreto, PharmD, PhD — Mayo Clinic
- Study coordinator: Gerald W. Flaby Jr., LRT, RRT
- Email: flaby.gerald@mayo.edu
- Phone: 507-422-3462
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.