Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients
|ClinicalTrials.gov Identifier: NCT02011841|
Recruitment Status : Withdrawn (We failed to recruit patients)
First Posted : December 13, 2013
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spontaneous Bacterial Peritonitis||Drug: Rifaximin Drug: Ciprofloxacin||Phase 3|
- 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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||January 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Rifaximin group
Rifaximin 1200 mg/day orally for 6 months
rifaximin 1200 mg/day orally for 6 months
Other Name: Normix
Active Comparator: Control group
Ciprofloxacin 500 mg/day orally for 6 months
ciprofloxacin 500 mg/day orally for 6 months
- The recurrence rate of spontaneous bacterial peritonitis [ Time Frame: every 4 weeks, up to 24 weeks ]The proportion of patients who recurred spontaneous bacterial peritonitis.
- mortality [ Time Frame: up to 24 weeks ]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 ]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 ]Causative bacteria of recurrent spontaneous bacterial peritonitis and susceptibility
- Change of gut microbiota [ Time Frame: at baseline, week 12 ]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 ]Infections other than spontaneous bacterial peritonitis (i.e. urinary tract infection, respiratory tract infection, etc.)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011841
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jeong-Hoon Lee, M.D., Ph.D.||Seoul National University Hospital|