Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial): A Randomized control trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 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
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.
• Patients in Rifaximin limb developing SBP will switch to Norfloxacin
• Patients in Norfloxacin limb developing SBP will switch to Rifaximin
Treatment Failure: Defined as development of SBP at end of 6 months or 1 year of treatment.
Study population: age >18 years with prior incident SBP
Study design: Randomised case controlled trial
Study period: 1year after ethical clearance
Sample size: 280 (140 in each arm)
Intervention: This RCT will be conducted at ILBS New Delhi
Monitoring and assessment: Monitoring will be done forall the parameters of the objective. Documentation will be done for any adverse effects which will happen.
STATISTICAL ANALYSIS: Assuming incidence of SBP over 6 months is 4% in Rifaximin & 15% in Norfloxacin
Alpha 5% and power 80%. Enrollment of 260 cases (130 in each arm). Assuming dropout rate 10%.Total study cases calculated as 280 (140 in each arm). Random allocation in each arm by block method taking 10 as block size
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age>18 years 2) Cirrhosis (of any etiology) with ascites 3) 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.
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 recurrence of SBP within12 months(12 months)
- Incidence of other site infections within 6 and 12 months(6 and 12 months)
- Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 6 and 12 months)(6 and 12 months)
- Transplant free survival by 6 and 12 months(6 and 12 months)
- Median change in CTP, MELD, MELD-Na scores by 6 months and 12 months(6 months and 12 months)
- Changes in gut microbiome in both groups by 6 and 12 months(6 months and 12 months)
- Side effects in both groups(12 months)
- Resistance patterns of infections in each group(12 months)
研究者
Dr Jayashree Biswas
Institute of Liver and Biliary Sciences