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

Spontaneous Bacterial Peritonitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02011841
• Other study ID #: Rifaximin_SBP
• Status: Withdrawn
• Phase: Phase 3
• First received: December 10, 2013
• Last updated: April 24, 2017
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis
• Recurrence
• Spontaneous Bacterial Peritonitis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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