Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05124977
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2021-11-15
Brief Title:
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
Status:
RECRUITING
Status Verified Date:
2023-11
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:
ASPIC
Brief Summary:
Increasing emergence of multidrug resistant MDR bacteria worldwide is now considered one of the most urgent threats to global health The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit ICU who received antibiotic treatment and for patients treated for ventilator associated pneumonia VAP
Reduction of use of antibiotics is a major point in the war against antimicrobial resistance VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP
Once the diagnosis of pneumonia under MV has been made initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration In the case of a good clinical response to treatment it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia CAP
The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality treatment failure or occurrence of new episode of pneumonia
The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation if it is obtained would be non-inferior in terms of all-cause mortality treatment failure or occurrence of new episode of pneumonia
This study will be a prospective national multicenter 31 centers phase III comparative randomized 11 single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms
Experimental group Antimicrobial stewardship based on daily clinical assessment of clinical cure
Control group standard management duration of appropriate antibiotic therapy for confirmed VAP according to guidelines
Reduction of use of antibiotics is a major point in the war against antimicrobial resistance VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP
Once the diagnosis of pneumonia under MV has been made initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration In the case of a good clinical response to treatment it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia CAP
The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality treatment failure or occurrence of new episode of pneumonia
The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation if it is obtained would be non-inferior in terms of all-cause mortality treatment failure or occurrence of new episode of pneumonia
This study will be a prospective national multicenter 31 centers phase III comparative randomized 11 single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms
Experimental group Antimicrobial stewardship based on daily clinical assessment of clinical cure
Control group standard management duration of appropriate antibiotic therapy for confirmed VAP according to guidelines
Detailed Description:
Increasing emergence of multidrug resistant MDR bacteria worldwide is now considered one of the most urgent threats to global health The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit ICU who received antibiotic treatment1 and for patients treated for ventilator associated pneumonia VAP Reduction of use of antibiotics is a major point in the war against antimicrobial resistance VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP Current international guidelines define VAP as a pneumonia occurring48 hours after endotracheal intubation and distinguishes early onset VAP occurring in the first five days after admission and late VAP occurring after
Once the diagnosis of pneumonia under MV has been made initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration In the case of a good clinical response to treatment it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia CAP
American guidelines strongly recommend a 7-day course of antibiotic therapy rather than a longer duration but remark that there exist situations in which a shorter or longer duration of antibiotics may be indicated depending upon the rate of improvement of clinical radiologic and laboratory parameters
The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality treatment failure or occurrence of new episode of pneumonia
The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation if it is obtained would be non-inferior in terms of all-cause mortality treatment failure or occurrence of new episode of pneumonia
This study will be a prospective national multicenter 31 centers phase III comparative randomized 11 single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms
Experimental group Antimicrobial stewardship based on daily clinical assessment of clinical cure
Control group standard management duration of appropriate antibiotic therapy for confirmed VAP according to guidelines
The primary endpoint is a hierarchical endpoint with a first non-inferiority criteria and a second efficacy criteria
Once the diagnosis of pneumonia under MV has been made initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration In the case of a good clinical response to treatment it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia CAP
American guidelines strongly recommend a 7-day course of antibiotic therapy rather than a longer duration but remark that there exist situations in which a shorter or longer duration of antibiotics may be indicated depending upon the rate of improvement of clinical radiologic and laboratory parameters
The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality treatment failure or occurrence of new episode of pneumonia
The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation if it is obtained would be non-inferior in terms of all-cause mortality treatment failure or occurrence of new episode of pneumonia
This study will be a prospective national multicenter 31 centers phase III comparative randomized 11 single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms
Experimental group Antimicrobial stewardship based on daily clinical assessment of clinical cure
Control group standard management duration of appropriate antibiotic therapy for confirmed VAP according to guidelines
The primary endpoint is a hierarchical endpoint with a first non-inferiority criteria and a second efficacy criteria
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