Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- number of patients with clearence of infection
研究概览
简要总结
Current European and most other international guidelines recommend the use of a third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or fluoroquinolones as an alternative choice .
These recommendations are based mainly on clinical trials that were very often conducted a decade or more ago, and on the assumption that E. coli would be involved in nearly half of the cases.
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis with ascites and SBP
排除标准
- •ascitic fluid with polymicrobial infections
研究组 & 干预措施
Cefotaxime
cefotaxime 2gm every 12 hours daily for 5 days
干预措施: Cefotaxime (Drug)
Ceftriaxone
ceftriaxone 2 gm every 24 hours for 5 days.
干预措施: ceftriaxone (Drug)
结局指标
主要结局
number of patients with clearence of infection
时间窗: 5 days
number of patients having clearence of infection
次要结局
未报告次要终点