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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jeong-Hoon Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02011841
First received: December 10, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Spontaneous Bacterial Peritonitis
Drug: Rifaximin
Drug: Ciprofloxacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients: A Prospective, Multicenter, Randomized, Open-label, Controlled Phase III Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The recurrence rate of spontaneous bacterial peritonitis [ Time Frame: every 4 weeks, up to 24 weeks ] [ Designated as safety issue: No ]
    The proportion of patients who recurred spontaneous bacterial peritonitis.


Secondary Outcome Measures:
  • mortality [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Causative bacteria of recurrent spontaneous bacterial peritonitis and susceptibility

  • Change of gut microbiota [ Time Frame: at baseline, week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Infections other than spontaneous bacterial peritonitis (i.e. urinary tract infection, respiratory tract infection, etc.)


Estimated Enrollment: 56
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifaximin group
Rifaximin 1200 mg/day orally for 6 months
Drug: Rifaximin
rifaximin 1200 mg/day orally for 6 months
Other Name: Normix
Active Comparator: Control group
Ciprofloxacin 500 mg/day orally for 6 months
Drug: Ciprofloxacin
ciprofloxacin 500 mg/day orally for 6 months

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011841

Contacts
Contact: Jeong-Hoon Lee, M.D., Ph.D. +82-2-2072-2228 pindra@empal.com

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jeong-Hoon Lee, M.D., Ph.D.       pindra@empal.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jeong-Hoon Lee, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jeong-Hoon Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02011841     History of Changes
Other Study ID Numbers: Rifaximin_SBP
Study First Received: December 10, 2013
Last Updated: December 10, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
liver cirrhosis
ascites
spontaneous bacterial peritonitis
recurrence

Additional relevant MeSH terms:
Peritonitis
Recurrence
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes
Ciprofloxacin
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014