Optimizing vancomycin dosing for obese adults

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

This study is testing the best way to give vancomycin to obese adults by comparing doses based on their weight versus their kidney function.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Michigan (other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT06601257 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the best way to dose vancomycin in obese adults by comparing dosing based on weight versus kidney function. Participants will be randomized into two groups, receiving a single dose of vancomycin either according to their weight or their kidney function after antihistamine pretreatment. The study will involve collecting blood and urine samples for pharmacokinetic analysis and measuring body composition using DEXA scans. The goal is to assess safety and efficacy of the different dosing strategies in achieving optimal drug exposure.

Who should consider this trial

Good fit: Ideal candidates are healthy obese adults aged 18 to 50 with a BMI of 30 or higher and specific kidney function criteria.

Not a fit: Patients with significant clinical illnesses, severe allergies, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer vancomycin dosing strategies for obese patients.

How similar studies have performed: While there have been studies on vancomycin dosing, this specific approach focusing on obesity and kidney function is relatively novel.

Eligibility criteria

Inclusion 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)

Exclusion Criteria:

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

Where this trial is running

Ann Arbor, Michigan

• Michigan Clinical Research Unit — Ann Arbor, Michigan, United States (RECRUITING)

Study contacts

• Study coordinator: Amit Pai, PharmD

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