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Anti-infective Agent

Cefazolin Dosing for Surgical Prophylaxis (MorphAbxPKSurg Trial)

Phase 4
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial seeks to determine if dosing by body composition vs. body weight can better prevent infection in overweight patients having surgery. Blood & fat tissue samples will be collected from participants during surgery.

Who is the study for?
This trial is for adults over 18 with a BMI of ≥25 kg/m^2 who are scheduled for surgery and expected to receive cefazolin. They must have had an abdominal CT scan before surgery and a creatinine clearance ≥90 mL/min, indicating good kidney function. Pregnant individuals or those with allergies to penicillin or cephalosporins cannot participate.
What is being tested?
The study tests if dosing the antibiotic cefazolin based on body composition rather than just weight can better prevent infections in overweight patients during surgery. It will compare blood and fat tissue concentrations of the drug when dosed by standard care versus morphomic analysis.
What are the potential side effects?
Cefazolin may cause side effects such as allergic reactions, pain at injection site, nausea, vomiting, diarrhea, rash, or abnormal liver tests. Severe reactions are rare but include severe allergy (anaphylaxis) and Clostridium difficile-associated diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Concentration Target Attainment
Secondary study objectives
Cefazolin exposure based on body depth
Cefazolin exposure based on kidney function

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Standard of CareActive Control1 Intervention
The patients assigned to this group have cefazolin dose assignments based on body weight, which is the standard of care.
Group II: Morphomic-basedActive Control1 Intervention
The patients assigned to this group have cefazolin dose assignments based on body depth and kidney function.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,434,957 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
406 Previous Clinical Trials
6,757,101 Total Patients Enrolled
~39 spots leftby Nov 2025
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