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Vancomycin Dose Optimization in Obesity

Description

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

Pharmacokinetics and Pharmacodynamics
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Pharmacokinetics and Pharmacodynamics

Study Overview

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Study Details

Study overview

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

An Open-Label, Single-Dose, Pharmacokinetic Study of Vancomycin Dosed by Weight or Kidney Function in Adults With Obesity

Vancomycin Dose Optimization in Obesity

Condition
Pharmacokinetics and Pharmacodynamics
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

Michigan Clinical Research Unit, Ann Arbor, Michigan, United States, 48108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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)
  • 2. Male or female adults age 18 to 50 years
  • 3. Weight ≥ 80 kg
  • 4. 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)
  • 1. Pregnant or lactating females
  • 2. Significant clinical illness within 3 weeks prior to screening
  • 3. History of severe allergic diseases including drug allergies, with the exception of seasonal allergies
  • 4. Patients initiated on GLP1 agonists
  • 5. 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.
  • 6. History of drug addiction or alcohol abuse within the past 12 months
  • 7. Any clinically significant abnormal lab values (Chemistry and Complete Blood Count) during screening
  • 8. Participants unwilling or unable to receive vancomycin by intravenous infusion
  • 9. Individuals with a history of psychiatric or neurological illness, including seizure disorders
  • 10. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
  • 11. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
  • 12. Pulse rate \<50 beats/minute or \>100 beats/minute.
  • 13. History of hypersensitivity or infusion reaction to vancomycin, cetirizine, or famotidine
  • 14. Participants with underlying hearing loss
  • 15. Participants that are taking ototoxic drugs

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Michigan,

Study Record Dates

2026-06