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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02120196
Acronym
SBP
Enrollment
100
Registered
2014-04-22
Start date
2014-01-31
Completion date
2023-12-31
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Bacterial Peritonitis, Ascites, Liver Cirrhosis

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.

Interventions

DRUGRifaximin

rifaximin 1200 mg daily versus norfloxacin 400 mg once daily

FDA approved:400mg once daily

Sponsors

Tanta University
CollaboratorOTHER
Sherief Abd-Elsalam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with recurrence of SBP6 monthsThe total number of paper of participitants with recurrence of SBP

Countries

Egypt

Contacts

Primary ContactSherief M. Abd-Elsalam, Lecturer
Sheif_tropical@yahoo.com00201000040794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026