Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial)

NCT06199843 | Unknown

• 1 other identifier: ILBS-SBP-03
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

SBP is a common complication of cirrhotics with associated increased mortality. After first episode of SBP there is increased risk of again developing SBP, with increased chance of developing resistant organism. So after the first episode of SBP, prophylaxis for prevention of second episode onwards is mandatory and therefore Rifaximin or Norfloxacin is considered. It has been seen that apart from preventing SBP they have other benefits with negligible side effects and therefore it is to be seen what other benefits including mortality benefits these drugs can confer.

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• Incidence of recurrence of SBP within 6 months

  6 months

Secondary Outcomes (15)

• Incidence of recurrence of SBP within12 months

  12 months

• Incidence of other site infections within 6 months

  6 months

• Incidence of other site infections within 12 months

  12 months

• to look for resistance pattern of infection in both norfloxacin and rifampicin group, type of resistant bacteria (MDR/XDR), and response of both groups to rifampicin and norfloxacin in secondary prophylaxis of SBP

  12 months

• Incidence of other complications (HE, variceal bleed, Refractory ascites, AKI) within 6 months

  6 months

Study Arms (2)

Rifaximin

EXPERIMENTAL

Rifaximin 550 mg BD

Drug: Rifaximin

Norfloxacin

ACTIVE COMPARATOR

Norfloxacin 400 mg OD

Drug: Norfloxacin

Interventions

Rifaximin DRUG

Rifaximin 550 mg BD

Rifaximin

Norfloxacin DRUG

Norfloxacin 400 mg OD

Norfloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• Cirrhosis (of any etiology) with ascites
• Prior incident SBP

You may not qualify if:

• Allergy to norfloxacin or rifaximin
• Recent history of upper gastrointestinal bleed (UGIB) within 2 weeks
• Patients with a history of multiple episodes of SBP
• Patients with inoperable or not treatable HCC or other non-hepatic malignancy
• Patients on immunosuppression
• HIV infected
• Post liver transplant
• Recent (\<6 months) abdominal surgery
• Pregnant/lactating women
• Other causes of ascites like tubercular or malignancy
• Patients developing SBP on Norfloxcacin

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Dr Jaya Benjamin

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Rifaximin; Norfloxacin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring

Central Study Contacts

Dr Jayashree Biswas, MD

CONTACT

01146300000; jayashreeb790@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: January 10, 2024
• Study Start: January 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-11

Locations

IN (1)