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

NCT06005168 | Completed Phase 4 FDA Drug

• 2 other identifiers: HUM00222771R01HS027183
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Prophylaxis

Keywords

Surgical Prophylaxis; Pharmacokinetics; Cefazolin; Obesity; Morphomics; Colorectal

Outcome Measures

Primary Outcomes (1)

• Proportion of Concentration Target Attainment

  Proportion of patients achieving at least 3.2 hours of time above 2 mcg/mL (MIC90) in subcutaneous fat tissue with the standard of care compared to morphomic-based dosing

  4 hours

Secondary Outcomes (2)

• Cefazolin exposure based on body depth

  4 hours

• Cefazolin exposure based on kidney function

  4 hours

Study Arms (2)

Standard of Care

NO INTERVENTION

The patients assigned to this group have cefazolin dose assignments based on body weight, which is the standard of care.

Morphomic-based

ACTIVE COMPARATOR

The patients assigned to this group have cefazolin dose assignments based on body depth and kidney function.

Drug: Cefazolin for Injection

Interventions

Cefazolin for Injection DRUG

2 grams or 3 grams based on standard of care or morphomic-based decision

Morphomic-based

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accessible abdominal computed tomography scan prior to surgery
• Adult patients \> 18 years of age
• Body Mass Index ≥ 25 kg/m\^2
• Expected to receive cefazolin prior to surgical incision
• Estimated creatinine clearance ≥90 mL/min

You may not qualify if:

• History of a hypersensitivity reaction to penicillin or cephalosporin
• Pregnancy

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Cefazolin; Injections

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is open label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: March 8, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)