Bacterial Infections in Patients With Cirrhosis in Argentina: Clinical and Microbiological Characteristics

Bacterial Infections in Patients With Cirrhosis in Argentina

In recent years, there has been an increasing prevalence of bacterial infections caused by multiresistant and extremely resistant organisms in patients with cirrhosis. These infections are associated with a worse prognosis, generate difficulties in the management of the patient during hospitalization and increase health costs.

The main objective of this project is to estimate the prevalence of infections by multiresistant bacteria in patients with cirrhosis. Additionally, the prevalence of other antibiotic resistance patterns and morbi-mortality in the study population will be evaluated.

For these purposes, a multicenter prospective cohort study will be carried out, including patients with cirrhosis who present bacterial infections at the time of admission, or during hospitalization.

Performing a study in Argentina on the clinical and microbiological characteristics of bacterial infections in patients with cirrhosis could be very useful to develop new strategies for prevention and treatment of this severe complication.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections; Cirrhosis; Morality; Resistant Infection
• Intervention / Treatment: Other: This is an observational study without intervention

• Study Type: Observational
• Enrollment (Actual): 444

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1643
    • Sebastián Marciano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients older than 17 years with cirrhosis who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized

Description

Inclusion Criteria:

• Patients with cirrhosis
• Patients older than 17 years.
• Patients who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized

Exclusion Criteria:

• Refusal to participate in the informed consent process

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To estimate the prevalence of infections caused by multi-resistant microorganisms in patients with cirrhosis	at the moment of the diagnosis of the bacerial infection

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate variables associated with infections caused by multi-resistant microorganisms in patients with cirrhosis	at the moment of the diagnosis of the bacerial infection
To evaluate the effect of infections caused by multi-resistant microorganisms on the in-hospital survival of patients with cirrhosis	30 days

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Liver Diseases; Bacterial Infections and Mycoses; Fibrosis; Infections; Communicable Diseases; Liver Cirrhosis; Bacterial Infections
• Other Study ID Numbers: 3879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No