Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis
NCT ID: NCT06005168
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
104 participants
INTERVENTIONAL
2023-03-08
2025-09-30
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Standard of Care
The patients assigned to this group have cefazolin dose assignments based on body weight, which is the standard of care.
No interventions assigned to this group
Morphomic-based
The patients assigned to this group have cefazolin dose assignments based on body depth and kidney function.
Cefazolin for Injection
2 grams or 3 grams based on standard of care or morphomic-based decision
Interventions
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Cefazolin for Injection
2 grams or 3 grams based on standard of care or morphomic-based decision
Eligibility Criteria
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Inclusion Criteria
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
2. Pregnancy
18 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
University of Michigan
OTHER
Responsible Party
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Manjunath Prakash Pai
Professor
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Amit P Pai, PharmD
Role: primary
Other Identifiers
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HUM00222771
Identifier Type: -
Identifier Source: org_study_id