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

NCT03965260 | Completed

• 1 other identifier: CRC_GHN_2019_005
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Bacterial results

  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.

  At inclusion

Study Arms (1)

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

Interventions

Bacterial samples from blood or peritoneal liquids BIOLOGICAL

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.

Bacteria-infected cirrhotic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bacteria-infected cirrhotic patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 29, 2019
• Study Start: November 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)