Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients

Overview

The aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.

Full Title of Study: “Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients: A Prospective, Multicenter, Randomized, Open-label, Controlled Phase III Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Detailed Description

– Rifaximin is an antibiotic with a broad-spectrum activity against gram-positive and gram-negative microorganisms, both aerobes and anaerobes within the gastrointestinal tract. The main advantage of rifaximin is that it is poorly absorbable, which minimizes the antimicrobial resistance and adverse events and renders the drug safe in all patient populations. In addition, rifaximin has a better activity against gram-positive organisms than norfloxacin. – The appreciation of the potential role of enteric flora in the pathogenesis of several gastrointestinal diseases has broadened the clinical use of rifaximin, which is now used for hepatic encephalopathy, small intestine bacterial overgrowth, inflammatory bowel disease, and Clostridium difficile infection. Theoretically, by reducing the total number of the gut bacteria, rifaximin could also be used to achieve intestinal decontamination in patients with liver cirrhosis and ascites, thus preventing spontaneous bacterial peritonitis. – A small retrospective study concluded that rifaximin suppresses intestinal bacterial overgrowth, bacterial translocation in cirrhotic patients with ascites with no history of previous spontaneous bacterial peritonitis episodes. Prospective clinical trials are warranted to evaluate the role of rifaximin for prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients.

Interventions

  • Drug: Rifaximin
    • rifaximin 1200 mg/day orally for 6 months
  • Drug: Ciprofloxacin
    • ciprofloxacin 500 mg/day orally for 6 months

Arms, Groups and Cohorts

  • Experimental: Rifaximin group
    • Rifaximin 1200 mg/day orally for 6 months
  • Active Comparator: Control group
    • Ciprofloxacin 500 mg/day orally for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • The recurrence rate of spontaneous bacterial peritonitis
    • Time Frame: every 4 weeks, up to 24 weeks
    • The proportion of patients who recurred spontaneous bacterial peritonitis.

Secondary Measures

  • mortality
    • Time Frame: up to 24 weeks
    • All-cause mortality and cause-specific mortality (mortality due to spontaneous bacterial peritonitis)
  • The recurrence of culture-negative spontaneous bacterial peritonitis
    • Time Frame: every 4 weeks, up to 24 weeks
    • The proportion of patients who recurred culture-negative spontaneous bacterial peritonitis.
  • Causative bacteria of recurrent spontaneous bacterial peritonitis
    • Time Frame: every 4 weeks, up to 24 weeks
    • Causative bacteria of recurrent spontaneous bacterial peritonitis and susceptibility
  • Change of gut microbiota
    • Time Frame: at baseline, week 12
    • Gut microbiota will be analyzed at baseline and week 12
  • Infections other than spontaneous bacterial peritonitis
    • Time Frame: every 4 weeks, up to 24 weeks
    • Infections other than spontaneous bacterial peritonitis (i.e. urinary tract infection, respiratory tract infection, etc.)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients diagnosed with cirrhosis based on clinical, biochemical, ultrasonographic and/or histological criteria – Patients who had recovered from an episode of spontaneous bacterial peritonitis – Age > 18 and <80 years Exclusion Criteria:

1. Decompensated cirrhotic patients with

  • serum bilirubin > 3.2 mg/dL – prothrombin time < 25% – serum creatinine > 3 mg/dL 2. Active gastrointestinal bleeding 3. Hepatic encephalopathy > grade 2 4. Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeong-Hoon Lee, Assistant Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jeong-Hoon Lee, M.D., Ph.D., Principal Investigator, Seoul National University Hospital

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