Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The efficacy of Rifaximin as a prophylactic treatment for SBP.
研究概览
简要总结
The goal of this Randomized controlled trial is to assessment the efficacy of Rifaximin as a prophylaxis of SBP in comparison with ciprofloxacin in Egyptian patients.
This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as; Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period and group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.
详细描述
This randomized controlled trial included 80 Egyptian patients diagnosed with cirrhotic liver disease and ascites just recovered from SBP attack grouped into two groups as;
- Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.
- Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
The included cases were collected from hepatology outpatient clinic and inpatient department at Ain shams University hospital between May 2023 and November 2023 after the scientific ethical committee approval. A written consent was obtained from the included cases.
Cases with metastatic HCC, patients with drug allergy from Ciprofloxacin or Rifaximin, those having ascites secondary to other causes rather than liver cirrhosis, those having gastroenterology malignancy, patients on immunotherapy, and HIV patients were all excluded from the trial. Before starting the trial, the all cases were diagnosed as SBP with ascitic fluid sample with polymorphonuclear cell count more than 250 cells /µL and received medical treatment of SBP according to EASL guidelines for treatment of SBP.
All patients of the two groups were followed up for recurrence of SBP for 6 months. The study endpoints would be SBP, death, compliance failure, or liver transplantation.
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
盲法说明
no masking
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
- 是
入选标准
- •cirrhotic liver disease patients with ascites just recovered from SBP attack.
- •Must be able to swallow tablets
排除标准
- •Cases with metastatic HCC.
- •patients with drug allergy from Ciprofloxacin or Rifaximin.
- •those having ascites secondary to other causes rather than liver cirrhosis.
- •those having gastroenterology malignancy.
- •patients on immunotherapy.
- •HIV patients.
研究组 & 干预措施
group (1)
Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.
干预措施: Rifaximin 550Mg Tab (Drug)
group (1)
Group (1) included 40 cases received Rifaximin as 550 mg twice daily dose for a six-months period.
干预措施: ascitic fluid sample (Diagnostic Test)
group (2)
Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
干预措施: Ciprofloxacin 750 MG (Drug)
group (2)
Group (2) included 40 cases received Ciprofloxacin as 750 mg once weekly dose for a six-months period.
干预措施: ascitic fluid sample (Diagnostic Test)
结局指标
主要结局
The efficacy of Rifaximin as a prophylactic treatment for SBP.
时间窗: All patients of the two groups were followed up for 6 months.
comparison between Rifaximin and Ciprofloxacin when used as a prophylaxis for the recurrence of SBP.
次要结局
未报告次要终点