Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03919032
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
SEBASTIAN MARCIANO, 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.


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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacterial Infections in Patients With Cirrhosis in Argentina
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : October 16, 2019
Estimated Study Completion Date : October 16, 2019

Resource links provided by the National Library of Medicine



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


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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


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
Layout table for location information
Argentina
Sebastián Marciano Recruiting
Buenos Aires, Argentina, 1643
Contact: Sebastián Marciano, MD, MsC    1150066086    sebastian.marciano@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires

Layout table for additonal information
Responsible Party: SEBASTIAN MARCIANO, Assistant Professor of Hepatology , Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03919032     History of Changes
Other Study ID Numbers: 3879
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Fibrosis
Liver Cirrhosis
Bacterial Infections
Pathologic Processes
Liver Diseases
Digestive System Diseases