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

NCT02011841 | Withdrawn Phase 3

• 1 other identifier: Rifaximin_SBP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spontaneous Bacterial Peritonitis

Keywords

liver cirrhosis; ascites; spontaneous bacterial peritonitis; recurrence

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of spontaneous bacterial peritonitis

  The proportion of patients who recurred spontaneous bacterial peritonitis.

  every 4 weeks, up to 24 weeks

Secondary Outcomes (5)

• mortality

  up to 24 weeks

• The recurrence of culture-negative spontaneous bacterial peritonitis

  every 4 weeks, up to 24 weeks

• Causative bacteria of recurrent spontaneous bacterial peritonitis

  every 4 weeks, up to 24 weeks

• Change of gut microbiota

  at baseline, week 12

• Infections other than spontaneous bacterial peritonitis

  every 4 weeks, up to 24 weeks

Study Arms (2)

Rifaximin group

EXPERIMENTAL

Rifaximin 1200 mg/day orally for 6 months

Drug: Rifaximin

Control group

ACTIVE COMPARATOR

Ciprofloxacin 500 mg/day orally for 6 months

Drug: Ciprofloxacin

Interventions

Rifaximin DRUG

rifaximin 1200 mg/day orally for 6 months

Also known as: Normix

Rifaximin group

Ciprofloxacin DRUG

ciprofloxacin 500 mg/day orally for 6 months

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis; Ascites; Recurrence

Interventions

Rifaximin; Ciprofloxacin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring

Study Officials

• Jeong-Hoon Lee, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

KR (1)