Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03965260
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2019-05-23
Brief Title:
Data Collection and Identification of Infection-responsible Bacterial Resistances in Cirrhotic Patients
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Data Collection and Identification of Infection-responsible Bacterial Resistances in Cirrhotic Patients
Status:
COMPLETED
Status Verified Date:
2022-03
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:
RECONNAISSANCE
Brief Summary:
Cirrhotic patients have a high risk of bacterial infection These infections induce systemic inflammation that can lead to acute liver failure or even acute liver failure associated with multi-visceral failure Acute-to-Chronic Liver Failure ACLF associated with an increased risk of short-term mortality in this population
The most common infections are spontaneous bacterial peritonitis and urinary tract infections followed by pneumonia skin and soft tissue infections and spontaneous bacteremia
In order to cope with the growing risk of resistant bacterial infections recommendations from the European Association for the Study of the Liver EASL were issued in 2014 and are followed by physicians treating cirrhotic patients These recommendations advocate taking into account different parameters regarding the best therapeutic strategy to adopt The site of the infection the mode of acquisition or the presence or absence of prophylaxis may modify this therapeutic approach to infections of cirrhotic patients to a greater or lesser extent However the ecology of a center varies over time according to the practices of the hospital center and to the different patients in care It is recommended to update the antibiotic resistance data in order to propose the best therapeutic strategy for these patients
The study of bacterial resistance in a given care center makes it possible to adapt the recommendations published by EASL in 2014 to the local ecology and to set up protocols of probabilistic antibiotic therapy adapted for a better efficiency
This descriptive cohort study will determine the local ecology of the center This will enable the center to assess if the recommended antibacterial strategies correspond to the center bacterial ecology
The most common infections are spontaneous bacterial peritonitis and urinary tract infections followed by pneumonia skin and soft tissue infections and spontaneous bacteremia
In order to cope with the growing risk of resistant bacterial infections recommendations from the European Association for the Study of the Liver EASL were issued in 2014 and are followed by physicians treating cirrhotic patients These recommendations advocate taking into account different parameters regarding the best therapeutic strategy to adopt The site of the infection the mode of acquisition or the presence or absence of prophylaxis may modify this therapeutic approach to infections of cirrhotic patients to a greater or lesser extent However the ecology of a center varies over time according to the practices of the hospital center and to the different patients in care It is recommended to update the antibiotic resistance data in order to propose the best therapeutic strategy for these patients
The study of bacterial resistance in a given care center makes it possible to adapt the recommendations published by EASL in 2014 to the local ecology and to set up protocols of probabilistic antibiotic therapy adapted for a better efficiency
This descriptive cohort study will determine the local ecology of the center This will enable the center to assess if the recommended antibacterial strategies correspond to the center bacterial ecology
Detailed Description:
Cirrhotic patients have a high risk of bacterial infection These infections induce systemic inflammation that can lead to acute liver failure or even acute liver failure associated with multi-visceral failure Acute-to-Chronic Liver Failure ACLF associated with an increased risk of short-term mortality in this population
Cirrhotic patients have a higher risk of infection than the general population because cirrhosis is associated with various changes in the innate and acquired immune response These changes alter the response to external pathogens leading to some immunodeficiency 3 Infection is one of the most common risk factors for ACLF and the prevalence of bacterial infections is approximately 25 -46 in hospitalized patients with acute liver decompensation
The most common infections are spontaneous bacterial peritonitis and urinary tract infections followed by pneumonia skin and soft tissue infections and spontaneous bacteremia
These infections can have various etiologies The site of infection and the mode of acquisition may affect the risk of infection with resistant bacteria The increasing diffusion of multidrug-resistant bacteria has made the management of cirrhotic patients and bacterial infections more complex
Early administration of effective antibiotic therapy is crucial for determining the patients prognosis This empirical treatment should be initiated at the earliest after diagnosis of the bacterial infection to avoid an increased mortality risk due to possible septic shock or associated multi-visceral failure ACLF The antibiotic treatment administered takes into account the type of infection the risk of resistant bacterial infection but also the severity of the infection However this antibiotic administration can also select multi-resistant bacteria and increase the risk of mortality of the cirrhotic patient
In order to cope with the growing risk of resistant bacterial infections recommendations from the European Association for the Study of the Liver EASL were issued in 2014 and are followed by physicians treating cirrhotic patients These recommendations advocate taking into account different parameters regarding the best therapeutic strategy to adopt The site of the infection the mode of acquisition or the presence or absence of prophylaxis may modify this therapeutic approach to infections of cirrhotic patients to a greater or lesser extent However the ecology of a center varies over time according to the practices of the hospital center and to the different patients in care It is recommended to update the antibiotic resistance data in order to propose the best therapeutic strategy for these patients
The study of bacterial resistance in a given care center makes it possible to adapt the recommendations published by EASL in 2014 to the local ecology and to set up protocols of probabilistic antibiotic therapy adapted for a better efficiency
This descriptive cohort study will determine the local ecology of the center This will enable the center to assess if the recommended antibacterial strategies correspond to the center bacterial ecology
Cirrhotic patients have a higher risk of infection than the general population because cirrhosis is associated with various changes in the innate and acquired immune response These changes alter the response to external pathogens leading to some immunodeficiency 3 Infection is one of the most common risk factors for ACLF and the prevalence of bacterial infections is approximately 25 -46 in hospitalized patients with acute liver decompensation
The most common infections are spontaneous bacterial peritonitis and urinary tract infections followed by pneumonia skin and soft tissue infections and spontaneous bacteremia
These infections can have various etiologies The site of infection and the mode of acquisition may affect the risk of infection with resistant bacteria The increasing diffusion of multidrug-resistant bacteria has made the management of cirrhotic patients and bacterial infections more complex
Early administration of effective antibiotic therapy is crucial for determining the patients prognosis This empirical treatment should be initiated at the earliest after diagnosis of the bacterial infection to avoid an increased mortality risk due to possible septic shock or associated multi-visceral failure ACLF The antibiotic treatment administered takes into account the type of infection the risk of resistant bacterial infection but also the severity of the infection However this antibiotic administration can also select multi-resistant bacteria and increase the risk of mortality of the cirrhotic patient
In order to cope with the growing risk of resistant bacterial infections recommendations from the European Association for the Study of the Liver EASL were issued in 2014 and are followed by physicians treating cirrhotic patients These recommendations advocate taking into account different parameters regarding the best therapeutic strategy to adopt The site of the infection the mode of acquisition or the presence or absence of prophylaxis may modify this therapeutic approach to infections of cirrhotic patients to a greater or lesser extent However the ecology of a center varies over time according to the practices of the hospital center and to the different patients in care It is recommended to update the antibiotic resistance data in order to propose the best therapeutic strategy for these patients
The study of bacterial resistance in a given care center makes it possible to adapt the recommendations published by EASL in 2014 to the local ecology and to set up protocols of probabilistic antibiotic therapy adapted for a better efficiency
This descriptive cohort study will determine the local ecology of the center This will enable the center to assess if the recommended antibacterial strategies correspond to the center bacterial ecology
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