NCT07287332 · Mayo Clinic
BLOOM: Pragmatic Feasibility Trial
What this study is about
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.
View original scientific description
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
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 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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Incarcerated
- Declined Minnesota research authorization
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2026 · Source of record for eligibility and locations