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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Up-front individualized dosing algorithm
Other interventionAn 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.
Usual Care
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Proportion 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
Distribution of qualified patients across care teams
Number of patients from each ICU care team who qualify for the study
Adherence to dosing recommendations
Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage
Secondary outcomes
Number of antibiotic-free days
Number of antibiotic-free days for the first 28 days
ICU length of stay
Number of days of initial ICU stay
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
Proportion of patients who experience clinical success
Complete or partial resolution of clinical signs and symptoms attributed to infection across 8 days of therapy.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.