BLOOM: Pragmatic Feasibility Trial

Mayo Clinic

Status: Enrolling

Conditions: Infection; Sepsis

Treatments: Other: Up-front individualized dosing algorithm; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07287332

25-004564

Details and patient eligibility

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. 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Up-front individualized dosing algorithm

Experimental group

Description:

Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight.

Treatment:

Other: Up-front individualized dosing algorithm

Usual Care

Active Comparator group

Description:

The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr.

Treatment:

Other: Usual Care