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

NCT03919032 | Completed

• 1 other identifier: 3879
• Study Type: observational
• Target: 472
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections; Cirrhosis; Resistant Infection; Morality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

This is an observational study without intervention OTHER

This is an observational study without intervention

Eligibility Criteria

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

You may qualify if:

• Patients with cirrhosis
• Patients older than 17 years.
• Patients who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized

You may not qualify if:

• Refusal to participate in the informed consent process

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Sebastián Marciano

Buenos Aires, Buenos Aires, 1643, Argentina

Location

Related Publications (2)

• Vazquez C, Gutierrez-Acevedo MN, Barbero S, Notari LDC, Agozino M, Fernandez JL, Anders MM, Grigera NL, Antinucci F, Orozco-Ganem ONF, Murga MD, Perez MD, Palazzo AG, Rejtman LM, Duarte IG, Vorobioff JD, Trevizan V, Bulaty S, Bessone F, Valverde M, Elizondo M, Borzi SM, Stieben TE, Masola AC, Ferretti SE, Arufe D, Demirdjian E, Raffa MP, Peralta M, Fainboim HA, Vazquez CE, Ruiz PM, Martinez JE, Heffner LA, Odzak A, Dirchwolf M, Smud A, Mendizabal M, Calzetta PA, Martinez A, Tomatis J, Bruno A, Ramos A, Pages J, Tevez S, Gadano AC, Giunta DH, Marciano S. Clinical and microbiological characteristics of bacterial infections in patients with cirrhosis. A prospective cohort study from Argentina and Uruguay. Ann Hepatol. 2023 Jul-Aug;28(4):101097. doi: 10.1016/j.aohep.2023.101097. Epub 2023 Apr 6.

  PMID: 37030570 DERIVED

• Marciano S, Gutierrez-Acevedo MN, Barbero S, Del C Notari L, Agozino M, Fernandez JL, Anders MM, Grigera N, Antinucci F, Orozco Ganem OF, Murga MD, Perez D, Palazzo A, Martinez Rejtman L, Duarte IG, Vorobioff J, Trevizan V, Bulaty S, Bessone F, Valverde M, Elizondo M, Bosia JD, Borzi SM, Stieben TE, Masola A, Ferretti SE, Arufe D, Demirdjian E, Raffa MP, Peralta M, Fainboim HA, Vazquez CE, Ruiz P, Martinez JE, Heffner LA, Odzak A, Dirchwolf M, Smud A, Mendizabal M, Bellizzi C, Martinez A, Tomatis J, Bruno A, Ramos A, Pages J, Tevez S, Gadano AC, Giunta DH. Norfloxacin prophylaxis effect on multidrug resistance in patients with cirrhosis and bacterial infections. Eur J Clin Microbiol Infect Dis. 2023 Apr;42(4):481-491. doi: 10.1007/s10096-023-04572-2. Epub 2023 Feb 23.

  PMID: 36820931 DERIVED

MeSH Terms

Conditions

Bacterial Infections; Fibrosis

Interventions

Methods

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Hepatology , Principal Investigator

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 18, 2019
• Study Start: October 16, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 13, 2025

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)