Spontaneous Bacterial Peritonitis
Conditions
Keywords
liver cirrhosis, ascites, spontaneous bacterial peritonitis, recurrence
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.
Interventions
DRUGRifaximin
rifaximin 1200 mg/day orally for 6 months
DRUGCiprofloxacin
ciprofloxacin 500 mg/day orally for 6 months
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 2. Active gastrointestinal bleeding 3. Hepatic encephalopathy \> grade 2 4. Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The recurrence rate of spontaneous bacterial peritonitis | every 4 weeks, up to 24 weeks | The proportion of patients who recurred spontaneous bacterial peritonitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of gut microbiota | at baseline, week 12 | Gut microbiota will be analyzed at baseline and week 12 |
| 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.) |
| mortality | 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 | 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 | every 4 weeks, up to 24 weeks | Causative bacteria of recurrent spontaneous bacterial peritonitis and susceptibility |
Countries
South Korea
Outcome results
None listed