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

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT02120196
Collaborator
Tanta University (Other)
100
Enrollment
1
Location
2
Arms
119
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with recurrence of SBP [6 months]

      The total number of paper of participitants with recurrence of SBP

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta university hospital Tanta Egypt

    Sponsors and Collaborators

    • Sherief Abd-Elsalam
    • Tanta University

    Investigators

    • Principal Investigator: Asem A Elfert, TUH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Dr, Tanta University
    ClinicalTrials.gov Identifier:
    NCT02120196
    Other Study ID Numbers:
    • Asem Ahmed Elfert
    First Posted:
    Apr 22, 2014
    Last Update Posted:
    Jan 9, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Peritonitis
    Liver Cirrhosis
    Ascites
    Rifaximin
    Norfloxacin

    Study Results

    No Results Posted as of Jan 9, 2018