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OpenTrials
Completed

NCT Number: NCT06005168

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48108, United States

About this study

The risk of surgical site infections are higher in patients with obesity compared to non-obese adults. Our group has previously demonstrated that radiologic measures of abdominal subcutaneous fat are associated with surgical site infection risk in patients undergoing colorectal surgeries, which could reflect suboptimal antibiotic exposure in these patients. Therefore, we hypothesized that measures of abdominal size and composition in patients undergoing colorectal surgery would be more predictive of antimicrobial pharmacokinetics in this tissue compartment than the current standards of body weight and BMI. We confirmed this hypothesis and identified kidney function and body depth (by morphomics) to be predictive of cefazolin exposure in target tissue. Morphomics is a technology that transforms existing computed tomography data into body measures and composition. This study is a head-to-head comparison of this new proposed morphomic test regimen to the standard of care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Cefazolin for Injection

Drug

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

Primary outcomes

  1. Proportion of Concentration Target Attainment

    Time frame: 4 hours

    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

Secondary outcomes

  1. Cefazolin exposure based on body depth

    Time frame: 4 hours

    Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with a body depth above and below 350 mm

  2. Cefazolin exposure based on kidney function

    Time frame: 4 hours

    Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with an estimated creatinine clearance above and below 120 mL/min

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: MorphAbxPKSurg

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2023
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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