RECRUITING

Vancomycin Dose Optimization in Obesity

Conditions

Pharmacokinetics and Pharmacodynamics obesity pharmacokinetics vancomycin antibiotics body composition kidney function renal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-04-01

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06601257

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.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Amit Pai, PharmD

CONTACT

7346470006

amitpai@med.umich.edu

Study Locations (Sites)

Michigan Clinical Research Unit

Ann Arbor, Michigan, 48108

United States

Collaborators and Investigators

Sponsor: University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

obesity
pharmacokinetics
vancomycin
antibiotics
body composition
kidney function
renal

Additional Relevant MeSH Terms

Pharmacokinetics and Pharmacodynamics