Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial): a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Incidence of recurrence of SBP within 6 months
研究概览
简要总结
SBP is a common complication of cirrhotics with associated increased mortality. After first episode of SBP there is increased risk of again developing SBP, with increased chance of developing resistant organism. So after the first episode of SBP, prophylaxis for prevention of second episode onwards is mandatory and therefore Rifaximin or Norfloxacin is considered. It has been seen that apart from preventing SBP they have other benefits with negligible side effects and therefore it is to be seen what other benefits including mortality benefits these drugs can confer.
详细描述
Hypothesis:-Rifaximin will be more effective in decreasing the incidence of SBP in patients with cirrhosis and prior episode of SBP
AIM:-.To study the efficacy and safety of Rifaximin vs Norfloxacin in preventing incident SBP, preventing non-SBP infections, and improving transplant free survival in patients with cirrhosis and previous episode of SBP
Methodology Single centered Open labeled Randomized Controlled Trial
Randomization will be done by block randomization method taking block size as 10. Data will be entered in Microsoft Excel and will be analysed by SPSS Version 28.Categorical Data will be represented as frequency (%) and will be analysed using Chi square or Fisher Exact Test as appropriate.Continuous Data will be represented as Mean +/- SD and compared using Student T test or Mann Whitney as per normality conditions are met or not.Beside this an appropriate analysis like survival analysis will be carried out at the time of Data Analysis.P value <0.05 will be considered as significant.
Rescue therapy: To be given to patients who develop SBP while on secondary prophylaxis, these patients will initially be treated by iv medication in hospital settings followed by change in therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Cirrhosis (of any etiology) with ascites
- •Prior incident SBP
排除标准
- •Allergy to norfloxacin or rifaximin
- •Recent history of upper gastrointestinal bleed (UGIB) within 2 weeks
- •Patients with a history of multiple episodes of SBP
- •Patients with inoperable or not treatable HCC or other non-hepatic malignancy
- •Patients on immunosuppression
- •HIV infected
- •Post liver transplant
- •Recent (<6 months) abdominal surgery
- •Pregnant/lactating women
- •Other causes of ascites like tubercular or malignancy
- •Patients developing SBP on Norfloxcacin
研究组 & 干预措施
Rifaximin
Rifaximin 550 mg BD
干预措施: Rifaximin (Drug)
Norfloxacin
Norfloxacin 400 mg OD
干预措施: Norfloxacin (Drug)
结局指标
主要结局
Incidence of recurrence of SBP within 6 months
时间窗: 6 months
次要结局
- Incidence of other site infections within 12 months(12 months)
- Incidence of other site infections within 6 months(6 months)
- to look for resistance pattern of infection in both norfloxacin and rifampicin group, type of resistant bacteria (MDR/XDR), and response of both groups to rifampicin and norfloxacin in secondary prophylaxis of SBP(12 months)
- Transplant free survival by 6 months(6 months)
- Change in Child-Turcotte-Pugh (CTP) by 6 months(6 months)
- Change in Model for End-Stage Liver Disease (MELD) scores by 12 months(12 months)
- Change in MELD-Na scores by 12 months(12 months)
- Side effects in both groups(12 months)
- Incidence of recurrence of SBP within12 months(12 months)
- Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 6 months(6 months)
- Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 12 months)(12 months)
- Transplant free survival by 12 months(12 months)
- Change in Model for End-Stage Liver Disease (MELD) scores by 6 months(6 months)
- Change in Model for End-Stage Liver Disease Sodium (MELD Na) scores by 6 months(6 months)
- Change in Child-Turcotte-Pugh (CTP) scores by 12 months(12 months)