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

Phase 3WithdrawnNCT02011841

Seoul National University Hospital

Overview

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

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Spontaneous Bacterial Peritonitis

Interventions

RifaximinDRUG

rifaximin 1200 mg/day orally for 6 months

CiprofloxacinDRUG

ciprofloxacin 500 mg/day orally for 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The recurrence rate of spontaneous bacterial peritonitis

The proportion of patients who recurred spontaneous bacterial peritonitis.

Time frame: every 4 weeks, up to 24 weeks

Secondary Outcomes

mortality

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

Time frame: up to 24 weeks

The recurrence of culture-negative spontaneous bacterial peritonitis

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

Time frame: every 4 weeks, up to 24 weeks

Causative bacteria of recurrent spontaneous bacterial peritonitis

Causative bacteria of recurrent spontaneous bacterial peritonitis and susceptibility

Time frame: every 4 weeks, up to 24 weeks

Change of gut microbiota

Gut microbiota will be analyzed at baseline and week 12

Time frame: at baseline, week 12

Infections other than spontaneous bacterial peritonitis

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

Time frame: every 4 weeks, up to 24 weeks

Data from ClinicalTrials.gov

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