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NCT02120196 Clinical Trial

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

Liver Cirrhosis Clinical Trial

— SBP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02120196
Other study ID # Asem Ahmed Elfert
Secondary ID
Status Recruiting
Phase Phase 3
First received April 7, 2014
Last updated January 5, 2018
Start date January 2014
Est. completion date December 2023

Study information
Verified date January 2018
Source Tanta University
Contact Sherief M. Abd-Elsalam, Lecturer
Phone 00201000040794
Email Sheif_tropical@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rifaximin
rifaximin 1200 mg daily versus norfloxacin 400 mg once daily
• Norfloxacin
FDA approved:400mg once daily

Locations
Country Name City State
Egypt Tanta university hospital Tanta

Sponsors (2)
Lead Sponsor Collaborator
Sherief Abd-Elsalam Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with recurrence of SBP The total number of paper of participitants with recurrence of SBP 6 months
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