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Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis (SBP)

Primary Purpose

Spontaneous Bacterial Peritonitis, Ascites, Liver Cirrhosis

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Rifaximin
Norfloxacin
Sponsored by
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spontaneous Bacterial Peritonitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previous episode of SBP
  • Total protein in the ascitic fluid below or equal to 1.5 g/dL

Exclusion Criteria:

  • Allergy to quinolones
  • Antibiotic therapy in the 2 weeks preceding inclusion
  • Recent ( within the previous 2 weeks) episode of digestive hemorrhage
  • Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
  • Pregnant and lactating women

Sites / Locations

  • Tanta university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rifaximin

norfloxacin

Arm Description

Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.

Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.

Outcomes

Primary Outcome Measures

Number of participants with recurrence of SBP
The total number of paper of participitants with recurrence of SBP

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
January 5, 2018
Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02120196
Brief Title
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Acronym
SBP
Official Title
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Recruiting
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.
Detailed Description
This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups : Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis, Ascites, Liver Cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rifaximin
Arm Type
Experimental
Arm Description
Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.
Arm Title
norfloxacin
Arm Type
Active Comparator
Arm Description
Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Gastrobiotic, Trencedia
Intervention Description
rifaximin 1200 mg daily versus norfloxacin 400 mg once daily
Intervention Type
Drug
Intervention Name(s)
Norfloxacin
Other Intervention Name(s)
Epinor
Intervention Description
FDA approved:400mg once daily
Primary Outcome Measure Information:
Title
Number of participants with recurrence of SBP
Description
The total number of paper of participitants with recurrence of SBP
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous episode of SBP Total protein in the ascitic fluid below or equal to 1.5 g/dL Exclusion Criteria: Allergy to quinolones Antibiotic therapy in the 2 weeks preceding inclusion Recent ( within the previous 2 weeks) episode of digestive hemorrhage Hepatocellular carcinoma or other neoplasias able to shorten life expectancy Pregnant and lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M. Abd-Elsalam, Lecturer
Phone
00201000040794
Email
Sheif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert
Organizational Affiliation
TUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
Phone
00201000040794
Email
Sherif_tropical@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

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