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

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

DRUG

Rifaximin

twice daily administration of 1 tablet containing 550 mg of active rifaximin

OTHER

Placebo

twice daily administration of 1 rifaximin placebo tablet

Sponsors & Collaborators

• Alfasigma S.p.A.

  collaborator INDUSTRY

• LC2 PHARMA

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Besancon

  lead OTHER

Principal Investigators

• Rodolphe Anty, MD · Centre Hospitalier Universitaire de Nice

• Edouard Bardou-Jacquet, MD · Rennes University Hospital

• Christophe Bureau, MD, PhD · University Hospital, Toulouse

• Vincent Di Martino, MD, PhD · CHRU de Besançon

• Claire Francoz, MD · Hôpital Beaujon, Clichy

• Alexandra Heurgue-Berlot, MD · CHU de Reims

• Marianne Latournerie, MD · Centre Hospitalier Universitaire Dijon

• Alexandre Louvet, MD, PhD · CHRU de Lille

• Pierre Nahon, MD, PhD · Hôpital Jean Verdier, Bondy

• Frédéric Oberti, MD · University Hospital, Angers

• Isabelle Rosa-Hezode, MD · CHIC de Créteil

• Marika Rudler, MD · Hôpital Pitié-Salpêtrière, APHP

• Matthieu Schnee, MD · Hôpital La Roche-sur-Yon

• Ghassan Riachi, MD · CHU Rouen

• Isabelle Ollivier, MD · CHU CAEN

• Eric Nguyen-Khac, MD, PhD · CHU Amiens

• Laure Elkrief, MD · CHU Tours

• Lucy Meunier, MD · University Hospital, Montpellier

• Fanny Lebosse, MD · Hopital de la Croix-Rousse

• Marie Noelle Hilleret, MD · University Hospital, Grenoble

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-05

Primary Completion

2022-06-03

Completion

2023-03-20

Countries

• France

Study Locations