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

Completed

• Conditions: Morality; Bacterial Infections; Cirrhosis; Resistant Infection

• Registration Number: NCT03919032
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sebastián Marciano; 🇦🇷 Buenos Aires, Argentina