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

January 5, 2018 updated by: Sherief Abd-Elsalam
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • tanta University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: rifaximin
Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.
Drug: Rifaximin
rifaximin 1200 mg daily versus norfloxacin 400 mg once daily
Other Names:
  • Gastrobiotic, Trencedia
ACTIVE_COMPARATOR: norfloxacin
Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.
Drug: Norfloxacin
FDA approved:400mg once daily
Other Names:
  • Epinor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with recurrence of SBP
Time Frame: 6 months
The total number of paper of participitants with recurrence of SBP
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Collaborators

Tanta University

Investigators

  • Principal Investigator: Asem A Elfert, TUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (ESTIMATE)

April 22, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asem Ahmed Elfert

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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