Efficacy of Rifaximin vs Norfloxacin for Secondary Prophylaxis of SBP (NORRIF Trial): a Randomized Control Trial

ILBS-SBP-03

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.

2024-01-05

2024-12-31

2024-12-31

Not yet recruiting

280

Inclusion Criteria: 1. Age\>18 years 2. Cirrhosis (of any etiology) with ascites 3. Prior incident SBP Exclusion Criteria: 1. Allergy to norfloxacin or rifaximin 2. Recent history of upper gastrointestinal bleed (UGIB) within 2 weeks 3. Patients with a history of multiple episodes of SBP 4. Patients with inoperable or not treatable HCC or other non-hepatic malignancy 5. Patients on immunosuppression 6. HIV infected 7. Post liver transplant 8. Recent (\<6 months) abdominal surgery 9. Pregnant/lactating women 10. Other causes of ascites like tubercular or malignancy 11. Patients developing SBP on Norfloxcacin

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

2024-01-10