- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120196
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis (SBP)
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Sherief M. Abd-Elsalam, Lecturer
- Phone Number: 00201000040794
- Email: Sheif_tropical@yahoo.com
Study Locations
-
-
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Tanta, Egypt
- Recruiting
- Tanta University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
rifaximin 1200 mg daily versus norfloxacin 400 mg once daily
Other Names:
|
ACTIVE_COMPARATOR: norfloxacin
Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.
|
FDA approved:400mg once daily
Other Names:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Asem A Elfert, TUH
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Peritoneal Diseases
- Liver Diseases
- Fibrosis
- Intraabdominal Infections
- Liver Cirrhosis
- Ascites
- Peritonitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Rifaximin
- Norfloxacin
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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