Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-24
Brief Title:
Model-informed Precision Dosing for Linezolid
Sponsor:
University of Hamburg-Eppendorf
Organization:
University of Hamburg-Eppendorf
Study Overview
Official Title:
Model-informed Precision Dosing for Linezolid a Pilot Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
LINEMAP
Brief Summary:
Study Rationale Previous in vitro and retrospective in vivo studies suggest that optimal linezolid concentrations between 2 and 7 mgL achieve clinical efficacy and microbiological eradication while minimizing side effects like thrombocytopenia and the emergence of resistance No prospective or randomized clinical trial has confirmed these findings and there is no consensus on how to adjust linezolid dosing to achieve optimal drug concentrations
Objectives The primary objective is to determine if model-informed precision dosing optimizes linezolid dosing to achieve therapeutic trough concentrations compared to a standard dose Secondary objectives include assessing the PKPD profile investigating the prevalence of linezolid resistance among gram-positive bacteria assessing microbiological resolution of infection and evaluating the safety and tolerability of linezolid
Methodology This study is an open monocentric pilot randomized controlled trial with two arms standard dose therapy versus dose adjustment based on model-informed precision dosing using therapeutic drug monitoring and PKPD targets developed in TMDx software
Sample Size 28 patients 14 in each group Assumptions are based on only 25 of patients in intensive care achieving the optimal therapeutic range with standard dosing compared to an expected 80 achieving this with model-informed precision dosing
Selection Criteria Adult patients 18 years already starting linezolid treatment for gram-positive infections expected to require treatment beyond the next calendar day Exclusions include imminent death expected or confirmed pregnancy expected linezolid treatment of less than 4 days or more than 4 weeks
Outcomes The primary endpoint is defined as the difference in the proportion of patients in the intervention and in the control groups who maintained a trough linezolid concentration of 2 to 7 mgL on Day 7 and Day 13
Objectives The primary objective is to determine if model-informed precision dosing optimizes linezolid dosing to achieve therapeutic trough concentrations compared to a standard dose Secondary objectives include assessing the PKPD profile investigating the prevalence of linezolid resistance among gram-positive bacteria assessing microbiological resolution of infection and evaluating the safety and tolerability of linezolid
Methodology This study is an open monocentric pilot randomized controlled trial with two arms standard dose therapy versus dose adjustment based on model-informed precision dosing using therapeutic drug monitoring and PKPD targets developed in TMDx software
Sample Size 28 patients 14 in each group Assumptions are based on only 25 of patients in intensive care achieving the optimal therapeutic range with standard dosing compared to an expected 80 achieving this with model-informed precision dosing
Selection Criteria Adult patients 18 years already starting linezolid treatment for gram-positive infections expected to require treatment beyond the next calendar day Exclusions include imminent death expected or confirmed pregnancy expected linezolid treatment of less than 4 days or more than 4 weeks
Outcomes The primary endpoint is defined as the difference in the proportion of patients in the intervention and in the control groups who maintained a trough linezolid concentration of 2 to 7 mgL on Day 7 and Day 13
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