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

Seoul National University

Status and phase

Withdrawn

Phase 3

Conditions

Spontaneous Bacterial Peritonitis

Treatments

Drug: Rifaximin

Drug: Ciprofloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT02011841

Rifaximin_SBP

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Decompensated cirrhotic patients with
- serum bilirubin > 3.2 mg/dL
- prothrombin time < 25%
- serum creatinine > 3 mg/dL
Active gastrointestinal bleeding
Hepatic encephalopathy > grade 2
Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma