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

Phase 3

• Conditions: Spontaneous Bacterial Peritonitis; Ascites; Liver Cirrhosis
• Interventions: Drug: Rifaximin; Drug: Norfloxacin

• Registration Number: NCT02120196
• Lead Sponsor: Sherief Abd-Elsalam

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.

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-22
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rifaximin	Rifaximin	Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.
norfloxacin	Norfloxacin	Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Number of participants with recurrence of SBP	6 months	The total number of paper of participitants with recurrence of SBP

Trial Locations

Locations (1)

Tanta university hospital; 🇪🇬 Tanta, Egypt