Comparison of Intravenous Ciprofloxacin and Intravenous Ceftriaxone in the Management of Spontaneous Bacterial Peritonitis in Cirrhosis of Liver
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- percentage of efficacy
研究概览
简要总结
Spontaneous bacterial peritonitis (SBP) is one of the leading causes of morbidity and mortality in patients with cirrhosis. Spontaneous bacterial peritonitis (SBP) is a common 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%1. Early diagnosis and a prompt antibiotic therapy have considerably decreased the mortality rate associated with an episode of SBP from 80% to approximately 20- 30% in the last decade. It is secondary to impaired humoral and cellular immune responses that results in indirect intestinal bacterial translocation into the ascitic fluid 2,3. The incidence of spontaneous bacterial peritonitis in hospitalised patients with cirrhosis varies from 7-23% in the West. It is around 33% in Pakistan. Translocation of bacteria (mostly gram negative) from the intestinal lumen due to decreased phagocytic activity of macrophages and increased intestinal permeability in cirrhotic patients is an important step in the development of spontaneous bacterial peritonitis. Spontaneous bacterial peritonitis is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year
详细描述
Recent attention drawn to the changing microbial and resistance patterns attributed to the increasing use of antibiotic prophylaxis and invasive procedures in such patients further underscores the importance of identifying the causative pathogen to ensure adequate antibiotic coverage 5,6. Symptomatic spontaneous bacterial peritonitis can be present as first presentation of ascites in chronic liver
Page | 4disease patients7. Patients with spontaneous bacterial peritonitis has a mortality rate ranging between 30-50%8 early diagnosis and prompt treatment with antibiotic can save patients lives9.
Different options in antibiotics are ceftriaxone, cefotaxime, ampicillin, ciprofloxacin, ofloxacin and metronidazole. Cefotaxime or ceftriaxone were considered the first-choice antibiotic for empirical treatment in cirrhotic patients developing spontaneous bacterial peritonitis. It has been suggested that ciprofloxacin could be an alternative to cefotaxime or ceftriaxone in cirrhotic patients developing spontaneous bacterial peritonitis 7
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with spontaneous bacterial peritonitis:
- •Child Pugh class A, B and C, confirmed from record file of the patient. Male and female patients from the age of 25-70 years with liver cirrhosis
排除标准
- •Hemorrhagic or malignant ascites. (on history).
- •Tuberculous with secondary peritonitis (on medical record file).
- •Hepatocellular carcinoma
研究组 & 干预措施
intravenous ceftriaxone
干预措施: intravenous ceftriaxone (Drug)
intravenous ciprofloxacin
干预措施: intravenous ciprofloxacin (Drug)
结局指标
主要结局
percentage of efficacy
时间窗: 1 month
efficacy of treatment will be determined by means of evaluating clinical symptoms, i.e., decrease in temperature to normal 98.6°F, absence of abdominal pain, reduction of the ascitic fluid neutrophil count to \<250 cells /mm³ after 48 hours of antibiotic therapy. Fever : Oral temperature \>38° C measured using a digital thermometer
次要结局
未报告次要终点
研究者
Dr Mudassar Saeed Pansota
Professor
Shahida Islam Medical Complex