Status:
RECRUITING
Vancomycin Dose Optimization in Obesity
Lead Sponsor:
University of Michigan
Conditions:
Pharmacokinetics and Pharmacodynamics
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 strateg...
Detailed Description
This prospective, dosing group-randomized, single-dose pharmacokinetic study aims to evaluate vancomycin dosing in healthy obese participants across three BMI and two kidney function categories. Twent...
Eligibility Criteria
Inclusion
- 24 healthy obese participants within three obese class groups; BMI 30-34.9 kg/m2 (n=8), BMI 35-39.9 kg/m2 (n=8), and BMI ≥ 40 kg/m2 (n=8)
- Male or female adults age 18 to 50 years
- Weight ≥ 80 kg
- Estimated creatinine clearance of 60 mL/min to 119 mL/min (n=12) or ≥ 120 mL/min (n=12) (based on the Cockcroft-Gault equation and dosing weight)
Exclusion
- Pregnant or lactating females
- Significant clinical illness within 3 weeks prior to screening
- History of severe allergic diseases including drug allergies, with the exception of seasonal allergies
- Patients initiated on GLP1 agonists
- Any other factor, condition, or disease, including but not limited to cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the opinion of the Investigator, jeopardize the safety of the participant or impact the validity of the study results.
- History of drug addiction or alcohol abuse within the past 12 months
- Any clinically significant abnormal lab values (Chemistry and Complete Blood Count) during screening
- Participants unwilling or unable to receive vancomycin by intravenous infusion
- Individuals with a history of psychiatric or neurological illness, including seizure disorders
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
- Pulse rate \<50 beats/minute or \>100 beats/minute.
- History of hypersensitivity or infusion reaction to vancomycin, cetirizine, or famotidine
- Participants with underlying hearing loss
- Participants that are taking ototoxic drugs
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06601257
Start Date
April 1 2025
End Date
June 1 2026
Last Update
May 30 2025
Active Locations (1)
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1
Michigan Clinical Research Unit
Ann Arbor, Michigan, United States, 48108