Prediction of Multidrug-resistant Bacterial Infection in Patients with Cirrhosis

NCT05641025 | Completed

• 1 other identifier: 3879_1
• Study Type: observational
• Target: 1,774
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to identify predictive factors of infections caused by multidrug-resistant organisms in patients with cirrhosis and to develop and validate (internally and externally) a predictive model that might be useful to use in clinical settings to stratify the risk and lead clinical decision-making strategies.

Conditions

Drug Resistance, Multiple; Bacterial Infections; Liver Cirrhosis

Keywords

bacterial infections; cirrhosis; multidrug resistance; antibiotic stewardship; prediction; risk

Outcome Measures

Primary Outcomes (1)

• Infection caused by multidrug-resistan organism

  Aqcuired resitance to at least one antibiotic of three different antibiotic families

  24-48 hours (it is a cross sectional study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

in-hospital adult patients with cirrhosis and bacterial infections

You may qualify if:

• age ≥ 18 years
• with cirrhosis
• who presented their first confirmed diagnosis of bacterial infection during the study period, either at admission or during hospitalization

You may not qualify if:

• hepatocellular carcinoma beyond the Milan criteria;
• extrahepatic malignancy;
• severe extrahepatic disease (congestive heart failure \[New York Heart Association stage3\], chronic obstructive pulmonary disease \[Global Initiative for Chronic Obstructive Lung Disease stage 3\]; chronic kidney disease requiring renal replacement therapy \[RRT\]);
• previous solid organ transplantation;
• human immunodeficiency viral infection;
• use of immunosuppressive drugs other than corticosteroids for the treatment of severe acute alcoholic hepatitis; and
• inability to provide written informed consent.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• International Club of Ascites: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, 1643, Argentina

Location

MeSH Terms

Conditions

Bacterial Infections; Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastián Marciano, MD, MsC

  Hospital Italiano de Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Hepatology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 7, 2022
• Study Start: November 16, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

AR (1)