Clinical trial NCT02011841: Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Spontaneous Bacterial Peritonitis
Keywords: liver cirrhosis
ascites
spontaneous bacterial peritonitis
recurrence
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: The recurrence rate of spontaneous bacterial peritonitis
timeFrame: every 4 weeks, up to 24 weeks
Secondary outcomes:
measure: mortality
timeFrame: up to 24 weeks
measure: The recurrence of culture-negative spontaneous bacterial peritonitis
timeFrame: every 4 weeks, up to 24 weeks
measure: Causative bacteria of recurrent spontaneous bacterial peritonitis
timeFrame: every 4 weeks, up to 24 weeks
measure: Change of gut microbiota
timeFrame: at baseline, week 12
measure: Infections other than spontaneous bacterial peritonitis
timeFrame: every 4 weeks, up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong-Hoon Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: