International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age17+
SponsorHospital Italiano de Buenos Aires
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Episodes of culture-confirmed bacterial infections
Patients diagnosed with cirrhosis
Infections diagnosed either at the time of hospital admission or during hospitalization
Disqualifiers
History of solid organ or hematopoietic stem cell transplantation
Declined to participate in the study
Trial population
Hospitalized patients in Latin American countries
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
1 week2
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.
Time frame
1 week3
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.
Time frame
1 weekSecondary outcomes
1
Proportion of episodes on infection susceptible to quinolones
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to quinolones as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to quinolones for the episode to be considered susceptible.
Time frame
1 week2
Proportion of episodes of infection susceptible to nitrofurantoin
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to nitrofurantoin as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to nitrofurantoin for the episode to be considered susceptible.
Time frame
1 week3
Proportion of episodes of infection susceptible to Trimethoprim-Sulfamethoxazole
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to Trimethoprim-Sulfamethoxazole as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to Trimethoprim-Sulfamethoxazole for the episode to be considered susceptible.
Time frame
1 week4
Proportion of episodes of infection susceptible to ceftriaxone
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to ceftriaxone as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to ceftriaxone for the episode to be considered susceptible.
Time frame
1 weekSponsors and contacts
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Source ClinicalTrials.gov