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Data Collection and Identification of Infection-responsible Bacterial Resistances in Cirrhotic Patients (RECONNAISSANCE)

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ClinicalTrials.gov Identifier: NCT03965260
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Cirrhosis Biological: Bacterial samples from blood or peritoneal liquids

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 patient's 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.

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Study Type : Observational
Estimated Enrollment : 480 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Collection and Identification of Infection-responsible Bacterial Resistances in Cirrhotic Patients
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bacteria-infected cirrhotic patients
All kind of etiologies for cirrhosis and all kind of bacterial infections (spontaneous bacterial peritonitis, urinary tract infections, pneumonia, skin and soft tissue infections and spontaneous bacteremia)
Biological: Bacterial samples from blood or peritoneal liquids

For each cirrhotic patient hospitalized for a bacterial infection, a blood sample or a peritoneal liquid sample was collected and analyzed for susceptibility, as it is performed in the standard of care. Our department receives only the bacterial results.

We will then describe the bacterial ecology of the center cirrhotic population in terms of infection acquisition mode, infection site, infection etiology but also drug-resistance.





Primary Outcome Measures :
  1. Bacterial results [ Time Frame: At inclusion ]
    A cirrhotic patient can have several sampling for bacterial analysis. Blood or peritoneal liquid samples are analyzed to identify the ecology of cirrhotic patients in the center. These bacteria will be described in terms of acquisition mode, infection site and drug-resistance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Bacteria-infected cirrhotic patients
Criteria

Inclusion Criteria:

  • Women and men ≥18 years of age
  • Cirrhosis diagnosis confirmed with a Doppler and/or a biopsy
  • bacterial infection documented with identified germ and susceptibility results
  • patient informed and non-opposed to participate

Exclusion Criteria:

  • cirrhotic patients with another infection than bacterial infection
  • legally protected patients
  • patients who expressed their opposition to participate to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965260


Contacts
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Contact: Fanny Lebossé, MD, PhD +33-4 26 10 93 39 fanny.lebosse@chu-lyon.fr
Contact: Nina Pronina, MSc nina.pronina@chu-lyon.fr

Locations
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France
Croix-Rousse Hospital, Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Fanny Lebossé, MD, PhD       fanny.lebosse@chu-lyon.fr   
Contact: Nina Pronina, MSc       nina.pronina@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03965260    
Other Study ID Numbers: CRC_GHN_2019_005
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes