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

Cirrhosis Clinical Trial

Official title:

Bacterial Infections in Patients With Cirrhosis in Argentina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919032
• Other study ID #: 3879
• Status: Completed
• Start date: October 16, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Cirrhosis
• Communicable Diseases
• Fibrosis
• Infection
• Liver Cirrhosis
• Morality
• Resistant Infection

Intervention

Other:
• This is an observational study without intervention
This is an observational study without intervention

Locations

Country	Name	City	State
Argentina	Sebastián Marciano	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To evaluate the effect of infections caused by multi-resistant microorganisms on the in-hospital survival of patients with cirrhosis		30 days