International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of multidrug-resistant organisms
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Episodes of culture-confirmed bacterial infections
- •Patients diagnosed with cirrhosis
- •Infections diagnosed either at the time of hospital admission or during hospitalization
排除标准
- •History of solid organ or hematopoietic stem cell transplantation
- •Declined to participate in the study
结局指标
主要结局
Proportion of multidrug-resistant organisms
时间窗: 1 week
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.
Proportion of extensively drug-resistant microorganisms
时间窗: 1 week
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.
Proportion of pan drug-resistant microorganisms
时间窗: 1 week
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.
次要结局
- 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)
- Proportion of episodes of infection susceptible to cefepime(1 week)
- Proportion of episodes of infection susceptible to aminoglycosides(1 week)
- Proportion of episodes of infection susceptible to piperacillin-tazobactam(1 week)
- Proportion of episodes of infection susceptible to ertapenem(1 week)
- Proportion of episodes of infection susceptible to meropenem/imipenem(1 week)
- Proportion of episodes of infection susceptible to colistin:(1 week)
- Proportion of episodes of infection susceptible to ceftazidime-avibactam(1 week)
- Proportion of episodes of infection susceptible to ceftolozane-tazobactam(1 week)
- Proportion of episodes of infection susceptible to piperacillin-tazobactam plus vancomycin(1 week)
- Proportion of episodes of infection susceptible to carbapenem plus vancomycin(1 week)
- Proportion of episodes of infection susceptible to carbapenem plus linezolid(1 week)
- Proportion of episodes of infection susceptible to carbapenem + linezolid(1 week)
- Proportion of episodes of infection susceptible to aminoglycoside + colistin(1 week)
- Proportion of episodes of infection susceptible to ceftazidime-avibactam + aztreonam(1 week)
- Proportion of episodes of infection susceptible to ceftazidime-avibactam + vancomycin(1 week)
研究者
SEBASTIAN MARCIANO. MD, MsC
Head of Hepatology
Hospital Italiano de Buenos Aires