Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis: an Open, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The primary end-point of the study is the response to therapy
研究概览
简要总结
Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug resistant bacteria. Standard treatment of SBP could be ineffective. The aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP.
详细描述
Spontaneous bacterial peritonitis (SBP) is a well known complication in patients with liver cirrhosis and ascites. Nosocomial SBP is defined as SBP that occurs after 48 hours of hospitalization. It has been shown that patients with nosocomial SBP have a worse prognosis than patients with community-acquired SBP. It has also been shown that nosocomial SBP is frequently caused by multi drug resistant bacteria such as extended-spectrum-beta-lactamase (ESBL) producing enterobacteria or meticillin - resistant staphylococcus aureus. Currently the empirical treatment of SBP is the use of third generation cephalosporins or amoxicillin/clavulanic acid. In patients affected by nosocomial SBP these treatment could be ineffective. Up to now an empirical approach with a broader spectrum strategy (such as an association between meropenem and daptomycin) has never been compared to standard therapy in the treatment of nosocomial SBP. Thus, the aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP in patients with cirrhosis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with liver cirrhosis and ascites
- •Meets all criteria for nosocomial SBP as outlined below
- •Ascitic fluid polymorphonuclear cells count >250/mm3
- •Onset of signs and symptoms of infection after 72 hours of hospitalization
排除标准
- •Hepatocellular carcinoma beyond the Milan criteria
- •Abdominal surgery within 4 weeks
- •Evidence of secondary peritonitis, pancreatitis or peritoneal carcinomatosis
- •Significant heart or respiratory failure
- •Allergy to ceftazidime, meropenem or daptomycin
研究组 & 干预措施
Daptomycin + Meropenem
30 patients with cirrhosis and nosocomial SBP
干预措施: Daptomycin + Meropenem (Drug)
Ceftazidime
30 patients with cirrhosis and nosocomial SBP
干预措施: Ceftazidime (Drug)
结局指标
主要结局
The primary end-point of the study is the response to therapy
时间窗: 48 hours and seven days
The response to therapy is defined as the reduction of polymorphonuclear leukocytes (PMN) count in ascitic fluid more than 25 % from baseline after 48 hours and as a PMN count in ascitic fluid less then 250/mm³ after seven days.
次要结局
- Mortality during hospitalization(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- 30 days mortality(30 days)
- 90 days mortality(90 days)