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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

MorphAbxPKSurg Trial 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.Check my eligibility

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.See study design

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.

MorphAbxPKSurg Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Concentration Target Attainment

Secondary outcome measures

Cefazolin exposure based on body depth

Cefazolin exposure based on kidney function

MorphAbxPKSurg 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,034 Total Patients Enrolled

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,822,244 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects is the current clinical trial accommodating?

"Affirmative. The details available on clinicaltrials.gov affirm that this medical trial, initially posted on March 8th 2023, is actively recruiting subjects for their experiment. 104 participants need to be recruited from one location."

Answered by AI

To what extent could Morphomic-based practices endanger individuals?

"Having already been approved, Morphomic-based technology was given a safety score of 3. This is due to the fact that it has reached Phase 4 clinical trial status."

Answered by AI

Is there an opportunity for prospective participants to join this research endeavor?

"Affirmative. According to the data showcased on clinicaltrials.gov, this medical study, which was first advertised on March 8th 2023, is still in search of participants. The research requires 104 individuals across a solitary location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stewart Wang 2023. "Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005168.