International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections

NCT06634940 | Recruiting DMC

• 1 other identifier: 5821
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

What is this study about? This study tracks antibiotic resistance in patients with cirrhosis who develop bacterial infections. Cirrhosis is a condition where the liver is severely scarred, and people with cirrhosis are at high risk for serious bacterial infections. Why is this study important? Bacterial infections are common in patients with cirrhosis, affecting 25-46% of those who are hospitalized. These infections can be life-threatening, with 1 in 4 patients dying from complications. Many of these infections are becoming harder to treat because the bacteria are resistant to antibiotics. Infections caused by resistant bacteria are increasing, which makes finding the right antibiotic quickly even more difficult. In other regions of the world, guidelines exist to help doctors choose the right antibiotics for cirrhosis patients. However, in Latin America, we don't have specific guidelines for our region, and doctors currently rely on recommendations from the U.S. or Europe. These guidelines may not reflect the local patterns of bacterial infections and resistance we see here. What is the goal of this study? The main goal of this study is to create a long-term system to track how bacteria respond to antibiotics in patients with cirrhosis in Latin America. By collecting data from hospitals across different countries, we aim to:

• Identify how many infections are caused by multidrug-resistant bacteria.
• Understand how antibiotics (such as ceftriaxone, vancomycin, and carbapenems) act against these infections.
• Generate reports informing bacterial resistance patterns to help doctors make better patient treatment decisions. What do we hope to achieve? We hope the data we collect will help develop guidelines for patients with cirrhosis in Latin America. These guidelines will ensure that doctors use the most effective antibiotics based on real-time data from our region. This should improve patient outcomes and help prevent the spread of resistant bacteria.

Conditions

Cirrhosis; Bacterial Infections; Multidrug Resistance

Keywords

antibiotics; empirical treatment; methicillin-resistant Staphylococcus aureus; extended-spectrum beta-lactamase-producing organisms; Carbapenemase-Producing Enterobacteriaceae; de-escalation; guidelines; empiric antibiotics

Outcome Measures

Primary Outcomes (3)

• Proportion of multidrug-resistant organisms

  Estimated by using the total number of bacterial infection episodes involving at least one multidrug-resistant organism as the numerator and the total number of bacterial infection episodes as the denominator.

  1 week

• Proportion of extensively drug-resistant microorganisms

  Estimated by using the total number of bacterial infection episodes involving at least one extensively drug-resistant microorganism as the numerator and the total number of bacterial infection episodes as the denominator.

  1 week

• Proportion of pan drug-resistant microorganisms

  Estimated by using the total number of bacterial infection episodes involving at least one pan drug-resistant microorganism as the numerator and the total number of bacterial infection episodes as the denominator.

  1 week

Secondary Outcomes (20)

• Proportion of episodes on infection susceptible to quinolones

  1 week

• Proportion of episodes of infection susceptible to nitrofurantoin

  1 week

• Proportion of episodes of infection susceptible to Trimethoprim-Sulfamethoxazole

  1 week

• Proportion of episodes of infection susceptible to ceftriaxone

  1 week

• Proportion of episodes of infection susceptible to ceftazidime

  1 week

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients in Latin American countries

You may qualify if:

• Episodes of culture-confirmed bacterial infections
• Patients diagnosed with cirrhosis
• Infections diagnosed either at the time of hospital admission or during hospitalization

You may not qualify if:

• History of solid organ or hematopoietic stem cell transplantation
• Declined to participate in the study

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., C1199ABB., Argentina

RECRUITING

MeSH Terms

Conditions

Fibrosis; Bacterial Infections

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sebastián M Marciano, Principal Investigator.

CONTACT

54 11 49590200; sebastian.marciano@hospitalitaliano.org.ar

Gonzalo Gomez Perdiguero, Registry coordinator

CONTACT

54 11 49590200; gonzalo.gomez@hospitalitaliano.org.ar,

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hepatology

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 10, 2024
• Study Start: November 15, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: form October 2024 to October 2030

Locations

AR (1)