Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 主要终点
- Prevention of Secondary Spontaneous Bacterial Peritonitis
研究概览
简要总结
the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.
详细描述
due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient 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
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis.
排除标准
- •Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.
研究组 & 干预措施
Control Group
They will receive standard therapy plus placebo
干预措施: Norfloxacin (Drug)
Nitazoxanide Group
They will receive standard therapy plus nitazoxanide
干预措施: Nitazoxanide (Drug)
Nitazoxanide Group
They will receive standard therapy plus nitazoxanide
干预措施: Norfloxacin (Drug)
结局指标
主要结局
Prevention of Secondary Spontaneous Bacterial Peritonitis
时间窗: 3 months
Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group
次要结局
- Change in Biological Biomarkers(3 months)
研究者
Eslam Mostafa Elasawy AlTaras
Clinical Pharmacist
Tanta University