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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Dec 27, 2023

Keywords

ClinConnect Summary

The NORRIF Trial is a study that aims to compare two medications, Rifaximin and Norfloxacin, to see which is better at preventing a serious condition called Spontaneous Bacterial Peritonitis (SBP) in people with liver disease (cirrhosis) who have already experienced this infection once. SBP is a dangerous complication that can occur in patients with cirrhosis, and it's important to prevent it from happening again. Both medications are thought to help not just with preventing SBP, but also to potentially improve overall health with very few side effects.

To be eligible for this trial, participants must be at least 18 years old, have cirrhosis along with fluid buildup in the abdomen (ascites), and have had a previous episode of SBP. However, there are certain conditions that would exclude someone from participating, such as recent gastrointestinal bleeding or certain other health issues. Those who join the trial can expect to receive either Rifaximin or Norfloxacin and will be monitored to see how well the treatment works and if it helps prevent another episode of SBP. This study is not yet recruiting participants, but it represents an important step in finding effective ways to manage this serious condition.

Gender

ALL

Eligibility criteria

• 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