Comparing antibiotic dosing methods for overweight surgical patients
Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis
PHASE4 · University of Michigan · NCT06005168
This study is testing if giving a different dose of an antibiotic based on body composition helps overweight surgical patients avoid infections better than the usual weight-based dosing.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06005168 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to compare the effectiveness of cefazolin dosing based on body composition versus the standard body weight-based dosing in overweight patients undergoing surgery. The researchers will analyze antibiotic concentrations in blood and fat tissue to determine if the morphomic-based dosing can improve infection prevention. Participants will provide small samples of blood and fat tissue during their scheduled surgeries, allowing for a direct comparison of antibiotic exposure. The study builds on previous findings that suggest obesity may lead to suboptimal antibiotic levels, increasing the risk of surgical site infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a Body Mass Index of 25 kg/m² or higher who are scheduled for surgery and expected to receive cefazolin.
Not a fit: Patients with a history of hypersensitivity to penicillin or cephalosporin, or those who are pregnant, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved antibiotic dosing strategies that reduce infection rates in overweight surgical patients.
How similar studies have performed: Previous studies have indicated that morphomic measurements can predict antibiotic exposure better than traditional methods, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Hospital — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Study coordinator: Amit P Pai, PharmD
- Email: amitpai@umich.edu
- Phone: 7346470006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgical Prophylaxis, Pharmacokinetics, Cefazolin, Obesity, Morphomics, Colorectal