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RECRUITING
NCT06601257
PHASE1

Vancomycin Dose Optimization in Obesity

Sponsor: University of Michigan

View on ClinicalTrials.gov

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 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

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-04-01

Completion Date

2026-06

Last Updated

2025-05-30

Healthy Volunteers

Yes

Interventions

DRUG

Vancomycin (IV)

Vancomycin weight-based or kidney function-based dosing

Locations (1)

Michigan Clinical Research Unit

Ann Arbor, Michigan, United States