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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03919032
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
SEBASTIAN MARCIANO, Hospital Italiano de Buenos Aires

Study Description
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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.


Condition or disease Intervention/treatment
Bacterial Infections Cirrhosis Resistant Infection Morality Other: This is an observational study without intervention

Study Design
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Study Type : Observational
Actual Enrollment : 444 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacterial Infections in Patients With Cirrhosis in Argentina
Actual Study Start Date : October 16, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: This is an observational study without intervention
    This is an observational study without intervention

Outcome Measures
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Primary Outcome Measures :
  1. To estimate the prevalence of infections caused by multi-resistant microorganisms in patients with cirrhosis [ Time Frame: at the moment of the diagnosis of the bacerial infection ]

Secondary Outcome Measures :
  1. To evaluate variables associated with infections caused by multi-resistant microorganisms in patients with cirrhosis [ Time Frame: at the moment of the diagnosis of the bacerial infection ]
  2. To evaluate the effect of infections caused by multi-resistant microorganisms on the in-hospital survival of patients with cirrhosis [ Time Frame: 30 days ]

Eligibility Criteria
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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:   Probability Sample
Study Population
Patients older than 17 years with cirrhosis who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized
Criteria

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

Contacts and Locations
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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): NCT03919032


Locations
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Argentina
Sebastián Marciano
Buenos Aires, Argentina, 1643
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
More Information
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Responsible Party: SEBASTIAN MARCIANO, Assistant Professor of Hepatology , Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03919032    
Other Study ID Numbers: 3879
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
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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Infections
Communicable Diseases
Bacterial Infections
Liver Cirrhosis
Fibrosis
 Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Bacterial Infections and Mycoses