BLOOM: Pragmatic Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults ≥18 years of age

• Admitted to one of the ICUs at the study center

• Prescribed cefepime therapy by the care team

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Gerald W. Flaby Jr., LRT, RRT
flaby.gerald@mayo.edu
507-422-3462
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2027-07
Participants
Target number of participants: 500
Treatments
Experimental: Up-front individualized dosing algorithm
Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight.
Active_comparator: Usual Care
The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov