NCT06601257CompletedPhase 1

Vancomycin Dose Optimization in Obesity

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

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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

Status (registry): Completed
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 35 (actual)
First submitted: 11 Sept 2024
Start date: 1 Apr 2025
Primary completion date: 27 Apr 2026
Lead sponsor: University of Michigan
Diseases: Obesity
NCT number: NCT06601257

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 35
From 1 Apr 2025 to the primary completion date, 27 Apr 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Significant clinical illness within 3 weeks prior to screening
Participants that are taking ototoxic drugs

Other illness

History of severe allergic diseases including drug allergies, with the exception of seasonal allergies
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
Individuals with a history of psychiatric or neurological illness, including seizure disorders
History of hypersensitivity or infusion reaction to vancomycin, cetirizine, or famotidine

Lab values

Any clinically significant abnormal lab values (Chemistry and Complete Blood Count) during screening

Other

Pregnant or lactating females
Patients initiated on GLP1 agonists
Participants unwilling or unable to receive vancomycin by intravenous infusion
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.
Participants with underlying hearing loss

Who the study is looking for

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)

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Michigan Clinical Research Unit Coordinator of this site? Confirm its status	Ann Arbor	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.