Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Recurrence of Spontaneous Bacterial Peritonitis (SBP)
研究概览
简要总结
The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:
Are nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP?
What medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin?
Researchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients.
Participants will:
Be randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day).
Undergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment.
Be monitored for any side effects and recurrence of SBP.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.
- •Ascitic patients diagnosed with Spontaneous Bacterial Peritonitis (SBP) by paracentesis.
- •Ascitic fluid polymorphonuclear (PMN) cell count > 250/mm³.
- •Age 50 years to 80 years.
- •Willing to provide informed consent.
排除标准
- •Pregnant or breastfeeding females.
- •History of allergic reactions to Norfloxacin, Nitazoxanide, or Colistin.
- •Patients with recurrent spontaneous peritonitis.
- •Presence of gastrointestinal hemorrhage.
- •Renal failure (Creatinine > 2 mg/dL or on dialysis).
- •Presence of severe infection-related sequelae (e.g., persistent fever, abdominal discomfort, sepsis).
研究组 & 干预措施
Norfloaxcin arm
patients to receive norflxacin 400mg daily
干预措施: Norfloxacin 400 MG (Drug)
Nitazoxaide arm
patients to receive nitazoxaide 500mg daily
干预措施: Nitazoxanide 500 MG (Drug)
Colisitn arm
patients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day
干预措施: Colistin (Drug)
结局指标
主要结局
Recurrence of Spontaneous Bacterial Peritonitis (SBP)
时间窗: Baseline, 3 months, and 6 months
Definition: The percentage of patients experiencing a recurrence of SBP within 6 months of treatment initiation. Measurement: Diagnosis confirmed by ascitic fluid analysis (PMN count \> 250 cells/mm³ and positive culture).
次要结局
- C-Reactive Protein (CRP) Reduction(Baseline, 1 month, 3 months, and 6 months)
- White Blood Cell (WBC) Count Reduction(Baseline, 1 month, 3 months, and 6 months)
- Renal Function Stability(Baseline, 3 months, and 6 months)