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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02011841
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Bacterial Peritonitis	Drug: Rifaximin; Drug: Ciprofloxacin	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rifaximin group Rifaximin 1200 mg/day orally for 6 months	Drug: Rifaximin; rifaximin 1200 mg/day orally for 6 months; Other Names: Normix
Active Comparator: Control group Ciprofloxacin 500 mg/day orally for 6 months	Drug: Ciprofloxacin; ciprofloxacin 500 mg/day orally for 6 months

Outcome Measures

Primary Outcome Measures

1. The recurrence rate of spontaneous bacterial peritonitis [every 4 weeks, up to 24 weeks]

   The proportion of patients who recurred spontaneous bacterial peritonitis.

Secondary Outcome Measures

1. mortality [up to 24 weeks]

   All-cause mortality and cause-specific mortality (mortality due to spontaneous bacterial peritonitis)

2. The recurrence of culture-negative spontaneous bacterial peritonitis [every 4 weeks, up to 24 weeks]

   The proportion of patients who recurred culture-negative spontaneous bacterial peritonitis.

3. Causative bacteria of recurrent spontaneous bacterial peritonitis [every 4 weeks, up to 24 weeks]

   Causative bacteria of recurrent spontaneous bacterial peritonitis and susceptibility

4. Change of gut microbiota [at baseline, week 12]

   Gut microbiota will be analyzed at baseline and week 12

5. Infections other than spontaneous bacterial peritonitis [every 4 weeks, up to 24 weeks]

   Infections other than spontaneous bacterial peritonitis (i.e. urinary tract infection, respiratory tract infection, etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Active gastrointestinal bleeding

2. Hepatic encephalopathy > grade 2

3. Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jeong-Hoon Lee, M.D., Ph.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeong-Hoon Lee, Assistant Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02011841
• Other Study ID Numbers: Rifaximin_SBP
• First Posted: Dec 13, 2013
• Last Update Posted: Apr 25, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Jeong-Hoon Lee, Assistant Professor, Seoul National University Hospital: liver cirrhosis; ascites; spontaneous bacterial peritonitis; recurrence
• Additional relevant MeSH terms: Peritonitis; Recurrence; Ciprofloxacin; Rifaximin

Study Results

No Results Posted as of Apr 25, 2017