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

Sherief Abd-Elsalam

Status and phase: Unknown; Phase 3

Conditions: Liver Cirrhosis; Spontaneous Bacterial Peritonitis; Ascites

Treatments: Drug: Norfloxacin; Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT02120196

Asem Ahmed Elfert

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

rifaximin

Experimental group

Description:

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

Treatment:

Drug: Rifaximin

norfloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Norfloxacin