BLOOM: Pragmatic Feasibility Trial Comparing Individualized Cefepime Dosing Algorithm Versus Usual Care in ICU Patients with Sepsis or Infection

What this Trial Is About

Researchers are evaluating two different dosing methods for cefepime, an antibiotic used in very sick patients with sepsis or infection. The study aims to compare the usual dosing approach with a new method that selects doses based on detailed patient information, including kidney function. This trial focuses on how easy it is for healthcare professionals to use the new dosing method and the best way to conduct the study, while also looking at patient recovery and side effects. Participants will be randomly assigned to one of two groups. One group will receive cefepime doses guided by an individualized dosing algorithm that uses estimated kidney function and weight, with recommendations provided through electronic health records and verified by pharmacists. The other group will receive standard care dosing based on institutional guidelines using estimated creatinine clearance categories. Care teams can adjust doses as needed. The study will last one year or until the sample size is reached. During the trial, researchers will monitor how many patients qualify and are distributed across care teams, as well as how well dosing recommendations are followed. Secondary outcomes include antibiotic-free days, ICU length of stay, development of antibiotic resistance, clinical and microbiologic success, and mortality within different time frames. Participants will be closely observed throughout their ICU stay with data collected to assess the impact of the dosing methods.

BLOOM: Pragmatic Feasibility Trial