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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
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.
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.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGProportion of patients screened who qualified for the study
Number of patients who quality for the study out of total number of patients screened, reported as a percentage
Time frame: 1 year or once the sample size is achieved
Distribution of qualified patients across care teams
Number of patients from each ICU care team who qualify for the study
Time frame: 1 year or once the sample size is achieved
Adherence to dosing recommendations
Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage
Time frame: 1 year or once the sample size is achieved
Number of antibiotic-free days
Number of antibiotic-free days for the first 28 days
Time frame: 28-days
ICU length of stay
Number of days of initial ICU stay
Time frame: 1 year
Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance
New anti-Pseudomonal beta-lactam resistance which develops within the 6 months following initial treatment
Time frame: 6 months
Proportion of patients who experience clinical success
Complete or partial resolution of clinical signs and symptoms attributed to infection across 8 days of therapy.
Time frame: 8 days
Proportion of patients who experience microbiologic success
Presumed or documented eradication of causative microorganisms
Time frame: 8 days
Mortality
All cause death
Time frame: 28-days
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