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

• Status: Unknown status
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Alfasigma S.p.A.; LC2 PHARMA
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Cirrhosis diagnosed on clinical, radiological and/or histological findings

• Patients with large ascites (i.e., grade 3 ascites requiring paracentesis).

• Ascites with a low protein level in ascitic fluid (< 15 g/L) with:

1. impaired renal function defined by serum creatinine ≥ 106 mmol/L, uremia ≥ 9 mmol/L or serum sodium ≤ 130 mmol/L), or

2. severe liver impairment defined by Child-Pugh score ≥ 9 with serum total bilirubin levels ≥ 51 mmol/L.

• Patient who signed an informed consent form

• Patient with a social security system

Exclusion Criteria:

• Pregnant woman or breastfeeding

• Person under 18 years of age and over 80 years of age

• Transplanted patients, HIV infection (or patients who deny HIV serology) or immunosuppressive therapy

• Past SBP or any present bacterial infection

• Patient with a TIPS

• Patient receiving antibiotics (including rifaximin) in the month preceding the inclusion in this study

• Hypersensitivity to rifaximin, derivatives of rifamycin or one of the constituents of the preparation

• Hepatocellular carcinoma outside the Milan criteria, other cancer at a palliative stage,

• Gastrointestinal bleeding within 7 days

• Grade 3 hepatic encephalopathy (HE) during the screening phase or at randomization or previous grade 3 HE

• Chronic heart failure (stage III or IV of the New York Heart Association [NYHA] Functional Classification

• Patient judged as noncompliant

• Patients who cannot receive a clear information and who have no trusted relatives

• Patient who refuses the participation agreement by signing the information form and consent as defined in the protocol.

• Exclusion period from another biomedical study