Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634940
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont have specific guidelines for our region and doctors currently rely on recommendations from the US 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
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 dont have specific guidelines for our region and doctors currently rely on recommendations from the US 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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This structure improves the flow and maintains a scientific tone Let me know if further revisions are needed
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
---
This structure improves the flow and maintains a scientific tone Let me know if further revisions are needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None