NCT03069131

Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites

A Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial Comparing Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites : Using or Not Using Rifaximin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in 'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month survival.

Conditions

• Cirrhosis
• Ascites
• Peritonitis

Interventions

Type	Name	Description
DRUG	Rifaximin	twice daily administration of 1 tablet containing 550 mg of active rifaximin
OTHER	Placebo	twice daily administration of 1 rifaximin placebo tablet

Timeline

• Start date: 2018-06-05
• Primary completion: 2022-06-03
• Completion: 2023-03-20
• First posted: 2017-03-03
• Last updated: 2025-04-10

Locations

18 sites across 1 country: France