Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
NCT ID: NCT02120196
Last Updated: 2018-01-09
Study Results
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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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2014-01-31
2023-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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rifaximin
Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.
Rifaximin
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.
Norfloxacin
FDA approved:400mg once daily
Interventions
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Rifaximin
rifaximin 1200 mg daily versus norfloxacin 400 mg once daily
Norfloxacin
FDA approved:400mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Total protein in the ascitic fluid below or equal to 1.5 g/dL
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Tanta University
OTHER
Sherief Abd-Elsalam
OTHER
Responsible Party
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Sherief Abd-Elsalam
Dr
Principal Investigators
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Asem A Elfert
Role: PRINCIPAL_INVESTIGATOR
TUH
Locations
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Tanta university hospital
Tanta, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Asem Ahmed Elfert
Identifier Type: -
Identifier Source: org_study_id
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