BLOOM: Pragmatic Feasibility Trial

ConditionsSepsisInfection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

Adults ≥18 years of age

Admitted to one of the ICUs at the study center

Prescribed cefepime therapy by the care team

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Up-front individualized dosing algorithm
  • Usual Care

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators