Actively Recruiting
Vancomycin Dose Optimization in Obesity
Led by University of Michigan · Updated on 2025-05-30
24
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. The main questions it aims to answer are: Does dosing vancomycin based on kidney function provide better drug exposure than dosing based on weight? What medical or safety issues arise when vancomycin is dosed according to weight versus kidney function? Participants will be randomized into two groups. One group will receive vancomycin doses based on their weight, while the other will receive doses based on their kidney function. Participants will: Receive a single dose of vancomycin based on either their weight or kidney function after pretreatment with antihistamines Provide blood and urine samples at specific times for pharmacokinetic analysis Undergo body composition measurements using DEXA scans and other methods Visit the clinic for physical exams, medical history, and laboratory tests
CONDITIONS
Official Title
Vancomycin Dose Optimization in Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy obese adults aged 18 to 50 years
- Body mass index (BMI) in one of three groups: 30-34.9 kg/m2, 35-39.9 kg/m2, or 40 kg/m2 and above
- Weight of 80 kilograms or more
- Estimated creatinine clearance between 60 mL/min to 119 mL/min or 120 mL/min and above based on Cockcroft-Gault equation and dosing weight
You will not qualify if you...
- Pregnant or breastfeeding females
- Significant illness within 3 weeks before screening
- History of severe allergies, except seasonal allergies
- Started treatment with GLP1 agonists
- Any serious heart, kidney, liver, or digestive disorders that may affect safety or study results
- History of drug addiction or alcohol abuse in the past 12 months
- Abnormal lab test results during screening
- Unable or unwilling to receive intravenous vancomycin
- History of psychiatric or neurological illness, including seizures
- Blood pressure outside 90-140 mm Hg systolic or 60-90 mm Hg diastolic range
- Pulse rate less than 50 or greater than 100 beats per minute
- History of allergic reaction to vancomycin, cetirizine, or famotidine
- Hearing loss
- Taking medications that can harm hearing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Michigan Clinical Research Unit
Ann Arbor, Michigan, United States, 48108
Actively Recruiting
Research Team
A
Amit Pai, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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