Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691309
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2022-12-29
Brief Title:
Optimizing Vancomycin Therapy in Children
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Optimizing Vancomycin Therapy in Children
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Opt Vanc
Brief Summary:
The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation based on a previously-developed population pharmacokinetic PK model and a single optimally timed PK sample to predict vancomycin area under the curve AUC in critically ill children
Detailed Description:
Opt Vanc is an observational study of critically ill children prescribed IV vancomycin for a suspected infection at the Childrens Hospital of Philadelphia This study will evaluate how well Bayesian dose adaptation based on a previously-developed population pharmacokinetic PK model for vancomycin and a single optimally timed vancomycin concentration can predict vancomycin area under the curve AUC in critically ill children Eligible subjects will be prescribed vancomycin and undergo routine therapeutic drug monitoring TDM per standard of care At the time of TDM each subject will have a vancomycin concentration obtained at the most informative sampling time to estimate AUC as determined by the multiple-model optimal sampling function in PMetrics population PK modeling program Investigators will then compare the AUC determined using Bayesian estimation and the subjects optimally timed vancomycin concentration to the AUC determined using Bayesian estimation with all available concentrations TDM samples plus the optimally timed sample Investigators will also examine how AUC estimation compares to AUC calculated using standard-of-care methods ie log-linear equations Further Investigators will evaluate how well the population PK model along with a subjects measured covariates and the optimally timed PK sample can predict a subjects future vancomycin AUC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K23HD091365 | NIH | None | httpsreporternihgovquickSearch5K23HD091365 |