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

NCT ID: NCT02120196

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Spontaneous Bacterial Peritonitis Ascites Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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rifaximin

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

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

rifaximin 1200 mg daily versus norfloxacin 400 mg once daily

norfloxacin

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

Group Type ACTIVE_COMPARATOR

Norfloxacin

Intervention Type DRUG

FDA approved:400mg once daily

Interventions

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Rifaximin

rifaximin 1200 mg daily versus norfloxacin 400 mg once daily

Intervention Type DRUG

Norfloxacin

FDA approved:400mg once daily

Intervention Type DRUG

Other Intervention Names

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Gastrobiotic, Trencedia Epinor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Asem A Elfert

Role: PRINCIPAL_INVESTIGATOR

TUH

Locations

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Tanta university hospital

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief M. Abd-Elsalam, Lecturer

Role: CONTACT

00201000040794

Facility Contacts

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Sherief Abd-Elsalam

Role: primary

00201000040794

Other Identifiers

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Asem Ahmed Elfert

Identifier Type: -

Identifier Source: org_study_id

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