Vancomycin Dose Optimization in Obesity

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

Timeline

Start

2025-04-01

Primary completion

2026-04-27

Completion

2026-04-27

Publications

• Background Pai MP. Antimicrobial Dosing in Specific Populations and Novel Clinical Methodologies: Kidney Function. Clin Pharmacol Ther. 2021 Apr;109(4):952-957. doi: 10.1002/cpt.2179. Epub 2021 Mar 3.
• Background Pai MP. Antimicrobial Dosing in Specific Populations and Novel Clinical Methodologies: Obesity. Clin Pharmacol Ther. 2021 Apr;109(4):942-951. doi: 10.1002/cpt.2181. Epub 2021 Feb 28.
• Background Pai MP, Derstine BA, Lichty M, Ross BE, Sullivan JA, Su GL, Wang SC. Relationships of Vancomycin Pharmacokinetics to Body Size and Composition Using a Novel Pharmacomorphomic Approach Based on Medical Imaging. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e01402-17. doi: 10.1128/AAC.01402-17. Print 2017 Nov.
• Background Crass RL, Dunn R, Hong J, Krop LC, Pai MP. Dosing vancomycin in the super obese: less is more. J Antimicrob Chemother. 2018 Nov 1;73(11):3081-3086. doi: 10.1093/jac/dky310.
• Background Rybak MJ, Le J, Lodise TP, Levine DP, Bradley JS, Liu C, Mueller BA, Pai MP, Wong-Beringer A, Rotschafer JC, Rodvold KA, Maples HD, Lomaestro BM. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020 May 19;77(11):835-864. doi: 10.1093/ajhp/zxaa036. No abstract available.

Drugs

Indications

No indication recorded.