Clinical trial NCT06634940: International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
Official title: International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients in Latin American countries

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.

Detailed description: Bacterial infections are among the most common complications in patients with cirrhosis, affecting 25-46% of those hospitalized. In two-thirds of cases, these infections are diagnosed during hospitalization, while the remainder develop during the hospital stay. The high mortality rate associated with these infections is significant, with one in four patients succumbing to the complication.

Regarding origin, 30-35% of bacterial infections in patients with cirrhosis are classified as spontaneous, with the rest being non-spontaneous. Spontaneous bacterial peritonitis is the most frequently reported infection specific to patients with cirrhosis and portal hypertension. Other spontaneous infections include spontaneous bacteremia and spontaneous bacterial empyema.

A significant factor influencing patient outcomes in bacterial infections is the rapid initiation of appropriate empirical antibiotic therapy. It is generally recommended that empirical treatment covers 80% of expected bacteria in stable patients and 90% in critically ill patients. However, this goal is increasingly challenging due to shifting epidemiology, with a rise in Gram-positive organisms and a growing incidence of multidrug resistance. Recent studies have shown that 34% of infections in patients with cirrhosis are caused by multidrug-resistant microorganisms, which are linked to poorer outcomes, complicating patient management, and increasing healthcare costs.

Although guidelines for empirical antibiotic treatment exist in other regions, none have been developed for Latin America. As a result, clinicians often rely on recommendations from the United States or Europe, which may not accurately reflect the epidemiology in this region.

GENERAL OBJECTIVES

1. To establish and sustain a surveillance system to monitor the antibiotic susceptibility patterns of microorganisms responsible for infections in patients with cirrhosis.
2. To produce periodic reports on evolving resistance patterns of microorganisms involved in infections in patients with cirrhosis.

EXPECTED OUTCOMES

This project aligns with global strategies to address the rise in infections caused by multidrug-resistant microorganisms. By applying a research methodology based on international standards, the study aims to ensure the collection of high-quality data that can lead to actionable outcomes.

Our research team initiated this project in 2020 to create a continuous surveillance program for bacterial infections in cirrhosis patients within our region. The goal is to collect and share real-time data on antibiotic susceptibility patterns.

We expect to generate results that will enable the production of detailed reports on the susceptibility patterns of bacterial infections in patients with cirrhosis at different levels. This will provide the necessary information to develop region-specific guidelines for the appropriate use of empirical antibiotics in this population. Additionally, periodic updates will reflect ongoing epidemiological changes.

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Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of multidrug-resistant organisms
timeFrame: 1 week
measure: Proportion of extensively drug-resistant microorganisms
timeFrame: 1 week
measure: Proportion of pan drug-resistant microorganisms
timeFrame: 1 week
Secondary outcomes:
measure: Proportion of episodes on infection susceptible to quinolones
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to nitrofurantoin
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to Trimethoprim-Sulfamethoxazole
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to ceftriaxone
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to ceftazidime
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to cefepime
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to aminoglycosides
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to piperacillin-tazobactam
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to ertapenem
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to meropenem/imipenem
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to colistin:
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to ceftazidime-avibactam
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to ceftolozane-tazobactam
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to piperacillin-tazobactam plus vancomycin
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to carbapenem plus vancomycin
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to carbapenem plus linezolid
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to carbapenem + linezolid
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to aminoglycoside + colistin
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to ceftazidime-avibactam + aztreonam
timeFrame: 1 week
measure: Proportion of episodes of infection susceptible to ceftazidime-avibactam + vancomycin
timeFrame: 1 week
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
References: