Vancomycin Dose Optimization in Obesity

Launched by UNIVERSITY OF MICHIGAN · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to find out the best way to give a medication called vancomycin to obese adults. The main goal is to see if using a person's kidney function to decide how much vancomycin to give is better than using their weight. The researchers want to understand how safe these different dosing methods are and what issues might come up from using one method over the other. Participants in the study will be divided into two groups: one will receive doses based on their weight, while the other will be dosed according to their kidney function.

To be eligible for the trial, participants need to be healthy adults aged 18 to 50 who are obese, with a body mass index (BMI) of at least 30. They should weigh at least 80 kg and have normal kidney function. Participants will receive a single dose of vancomycin, provide blood and urine samples, and undergo body composition tests during clinic visits. It's important to note that individuals with certain medical conditions or who are pregnant or breastfeeding cannot participate. This study aims to improve how vancomycin is given to ensure it is both effective and safe for patients with obesity.

Gender

ALL

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