Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601257
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Vancomycin Dose Optimization in Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Single-Dose Pharmacokinetic Study of Vancomycin Dosed by Weight or Kidney Function in Adults with Obesity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 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
Detailed Description:
This prospective dosing group-randomized single-dose pharmacokinetic study aims to evaluate vancomycin dosing in healthy obese participants across three BMI and two kidney function categories Twenty-four participants will be enrolled stratified by BMI 30-349 kgm² 35-399 kgm² 40 kgm² and creatinine clearance using dosing weight CLcr_dw 60-119 mLmin or 120 mLmin Twenty-four participants will be randomized 11 into a standard of care vancomycin group Control or a kidney function based group Test The study will include physical exams medical history and laboratory evaluations Vancomycin doses will be administered based on weight or kidney function Pharmacokinetic data will be collected through blood and urine samples at specific time points Body composition measurements will be performed using DEXA and through anthropometric methods Serum cystatin C concentrations will also be measured Data analysis will include fitting vancomycin concentration-time data using a 2-compartment linear model to estimate area under the curve AUC Group comparisons for AUC target attainment 400-600 hmgL will be performed using Fishers Exact Test Additionally the study will test if the investigators can reduce the standard two-sample method for AUC estimation to a single sample Different models of estimated glomerular filtration rate eGFR will be compared as predictors of vancomycin clearance CL This study will provide insights into optimizing vancomycin dosing in obese individuals with varying kidney function potentially improving therapeutic drug monitoring strategies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None