NCT03069131已完成3 期
A Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial Comparing Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites : Using or Not Using Rifaximin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 18
- 主要终点
- death
研究概览
简要总结
We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in 'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month survival.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis diagnosed on clinical, radiological and/or histological findings
- •Patients with large ascites (i.e., grade 3 ascites requiring paracentesis). Patients with grade 2 ascites are also authorized.
- •Ascites with a low protein level in ascitic fluid (< 15 g/L) with one of the following three conditions:
- •impaired renal function defined by serum creatinine ≥ 106 mmol/L, uremia ≥ 9 mmol/L or serum sodium ≤ 130 mmol/L), or
- •severe liver impairment defined by Child-Pugh score ≥ 9 with serum total bilirubin levels ≥ 51 mmol/L.
- •severe liver impairment defined by Child-Pugh C
- •Patient who signed an informed consent form
- •Patient with a social security system
- •Woman must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the study if childbearing potential.
- •Patients who needs a TIPS if the procedure is performed 3 months or more following the randomization
- •Patients with severe alcoholic hepatitis can be considered for inclusion if the MELD score < 30 and the Maddrey Discriminant Function < 60 providing that the patient is not infected (and consequently, will not receive antibiotics) and has not yet received corticosteroid (if necessary). Patients not responding to corticosteroid at day 7 (according to the Lille score) could be include after a wash-out of steroids for a period of 7 days.
排除标准
- •Pregnant woman or breastfeeding
- •Vulnerable person regarding french law
- •Individual under legal protection measure
- •Individual unable to exprim his/her consent
- •Person under 18 years of age and over 80 years of age
- •Transplanted patients, HIV infection (or patients who deny HIV serology) or immunosuppressive therapy (including patients under corticosteroids for severe alcoholic hepatitis if the patients respond to steroids with improvement of liver function)
- •Patients with a liver transplant project and an estimated waiting time for liver transplantation of 3 months or less
- •Past SBP or any present bacterial infection
- •Patient who have received a TIPS procedure before rhe randomization
- •Patients with an alfapump
- •Patient receiving antibiotics (including rifaximin) in the 7 days preceding the inclusion in this study exept for patients participating to the microbiota study (15 days).
- •Hypersensitivity to rifaximin, derivatives of rifamycin or one of the constituents of the preparation
- •Hepatocellular carcinoma outside the Milan criteria, other cancer at a palliative stage
- •Any clinical situation with a very low short-terme prognosis (other than cirrhosis), i.e. a survival estimated lower than one month
- •Gastrointestinal bleeding within 7 days
- •Intestinal obstruction
- •Grade 3 hepatic encephalopathy (HE) during the previous 6 months before randomization
- •Chronic heart failure (stage III or IV of the New York Heart Association [NYHA] Functional Classification
- •Patient judged as noncompliant
- •Patients who cannot receive a clear information and who have no trusted relatives
- •Patient who refuses the participation agreement by signing the information form and consent as defined in the protocol.
- •Exclusion period from another biomedical study
研究组 & 干预措施
Active rifaximin
Experimental
干预措施: Rifaximin (Drug)
Rifaximin placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
death
时间窗: 12 months
record of death whatever the cause
次要结局
- Hospital mortality rate and mortality rate at 3 months(3 months)
- Hospital mortality rate and mortality rate at 6 months(6 months)
- Incidence of spontaneous bacterial peritonitis (SBP) during follow-up(12 months)
- Incidence of the other complications of liver cirrhosis during follow-up(12 months)
- Patient hospitalizations during follow-up(12 months)
- Quantitative variations of IL-6 in serum between day 1 and day 30(1 month)
- Quantitative variations of lipopolysaccharides (LPS) in serum between day 1 and day 30(1 month)
- Quantitative variations of copeptin in serum between day 1 and day 30(1 month)
- Quantitative variations of CRP in serum between day 1 and day 30(1 month)
- Quantitative variations of von Willebrand Factor antigen in serum between day 1 and day 30(1 month)
- Composition of the intestinal microbiota(up to 18 months)
- Safety analysis of the study drug(12 months)
研究者
研究点 (18)
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