Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964114
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-01-24
Brief Title:
First Time Right of Vancomycin
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
None
Brief Summary:
In 2020 only 16 of the Intensive Care Unit ICU patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose Many beneficial population pharmacokinetic PPK models are available however these are prevented from being widely implemented in daily practice due to the complexity The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic PK tool
In a preceding retrospective study the percentage of patients within the target range after initiation of continuous vancomycin increased from 28 to 39 excluding CRRT and ECMO patients with calculated concentrations based on theoretical dose adjustments In this study we want to prospectively evaluate the concentration of vancomycin at 24 28 and 72 hours after the start of treatment with individualized dosages based on a combination of available PPK models in 134 adult ICU and orthopedic patients
In a preceding retrospective study the percentage of patients within the target range after initiation of continuous vancomycin increased from 28 to 39 excluding CRRT and ECMO patients with calculated concentrations based on theoretical dose adjustments In this study we want to prospectively evaluate the concentration of vancomycin at 24 28 and 72 hours after the start of treatment with individualized dosages based on a combination of available PPK models in 134 adult ICU and orthopedic patients
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None