跳至主要内容
临床试验/NCT02463721
NCT02463721Unknown不适用

Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis in Nile Delta and Its Impact on Clinical Outcome of These Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
identification of SBP bacterial pathogens through gram stain or other specific stains

研究概览

简要总结

Several studies have pointed out changes in the epidemiology of the causative bacteria in SBP and bacterascites and in their susceptibility to antibiotics. In particular, the development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum beta-lactamases in Escherichia coli. The potential emergence of enterococci, methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin prophylaxis, is also a cause of concern since they may be associated with a higher risk of therapeutic failure.

The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime), ciprofloxacin, and ofloxacin increased dramatically

详细描述

Spontaneous bacterial peritonitis (SBP), defined as an infection of ascites in the absence of a contiguous source of infection.

Spontaneous bacterial peritonitis (SBP) is a common and potentially fatal bacterial infection in patients with cirrhosis and ascites, occurring in 10 to 30% of patients, with in-hospital mortality rates ranging from 20 to 30% .

It is secondary to impaired humoral and cellular immune responses that result in indirect intestinal bacterial translocation into the ascitic fluid.

SBP is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year.

Early diagnosis and early optimal treatment of these infections with appropriate antibiotics and the prevention of hepatorenal syndrome with albumin are required .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Liver cirrhosis with ascites and suspected to have SBP.
  • ascitic fluid PMNL ≥ 250 cells/mm3

排除标准

  • ascitic fluid with polymicrobial infections
  • patients started empirical antibiotics without prior culture.

研究组 & 干预措施

SBP patients

Other

ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP

干预措施: ascitic fluid culture and microbiological testing (Other)

结局指标

主要结局

identification of SBP bacterial pathogens through gram stain or other specific stains

时间窗: 6 months

identification of SBP bacterial pathogens through gram stain or other specific stains

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherief Abd-Elsalam

PI

Tanta University

研究点 (1)

Loading locations...

相似试验