Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596096
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients BETALACTACRIT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Beta-lactams agents are time-dependent antibiotics Their bactericidal effects are associated with the time spent above the minimal inhibitory concentration MIC of the bacteria In ICU patients many pathophysiological changes may occur which significantly alter beta-lactam pharmacokinetics increasing in distribution volume hypoalbuminemia or change in glomerular filtration rate leading to antibiotic underexposure which may explain some treatment failures and risk of emergence of a multi-resistant bacteria
Many guidelines advocate to reach a fixed target for the steady-state free plasma concentration of beta-lactam between 4 and 8 times of the MIC However clinical evidences supporting that septic patients in ICU would benefit from such optimization remain low and contradictory and use of surrogate MICs based on critical breakpoints instead of actual MICs are significant limitations in the description of beta-lactam exposure among ICU patients with sepsis
In this study the investigators aim to indentify profiles of intensive care unit patients which are more likely to be associated with pharmacological failure 4 time the MIC of the bacteria The investigators also aim to identify association between failure and poor clinical outcome
Many guidelines advocate to reach a fixed target for the steady-state free plasma concentration of beta-lactam between 4 and 8 times of the MIC However clinical evidences supporting that septic patients in ICU would benefit from such optimization remain low and contradictory and use of surrogate MICs based on critical breakpoints instead of actual MICs are significant limitations in the description of beta-lactam exposure among ICU patients with sepsis
In this study the investigators aim to indentify profiles of intensive care unit patients which are more likely to be associated with pharmacological failure 4 time the MIC of the bacteria The investigators also aim to identify association between failure and poor clinical outcome
Detailed Description:
The duration of patient participation extends from the inclusion visit D1 to discharge from intensive care if the participant is still in intensive care at D90 the last visit with data collection will be at D90 The maximum duration of participation in the study will therefore be 3 months
Taking into account 3 months of set-up 1 year of recruitment 3 months of participant follow-up 3 months of data processing and 3 months of interpretation 2 years will be sufficient to carry out this project
Taking into account 3 months of set-up 1 year of recruitment 3 months of participant follow-up 3 months of data processing and 3 months of interpretation 2 years will be sufficient to carry out this project
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