Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis

HUM00222771

The goal of this clinical study is to compare the dosing of an antibiotic in overweight patients having surgery. The main question\[s\] it aims to answer are: * Are the antibiotic concentrations in blood and fat tissue in patients that are overweight sufficient to prevent the chance of infection? * Can dosing using body composition rather than body weight improve the chance of achieving good antibiotic concentrations in overweight patients? Participants will allow us to collect small amounts of blood and fat tissue during their regularly scheduled surgery. Researchers will compare differences in antibiotic concentrations based on dosing by standard of care (body weight based) versus body composition.

2023-03-08

2024-09-01

2024-12-31

Recruiting

Early phase I

104

Inclusion Criteria: 1. Accessible abdominal computed tomography scan prior to surgery 2. Adult patients \> 18 years of age 3. Body Mass Index ≥ 25 kg/m\^2 4. Expected to receive cefazolin prior to surgical incision 5. Estimated creatinine clearance ≥90 mL/min Exclusion Criteria: 1. History of a hypersensitivity reaction to penicillin or cephalosporin 2. Pregnancy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The current model for dosing the drug cefazolin includes the selection of 2 grams if the individual weighs less than 120 kg and 3 grams if they weigh 120 kg or more. The morphomic-based model defined the choice of 2 grams versus 3 grams of cefazolin based on kidney function and body depth.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is open label'}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}

2023-08-22