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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
CHU Amiens
Amiens, France
CHU d'Angers
Angers, France
CHU de Besançon
Besançon, France
death
record of death whatever the cause
Time frame: 12 months
Hospital mortality rate and mortality rate at 3 months
survival during hospitalization and at 3 months
Time frame: 3 months
Hospital mortality rate and mortality rate at 6 months
survival during hospitalization and at 6 months
Time frame: 6 months
Incidence of spontaneous bacterial peritonitis (SBP) during follow-up
Bacterial analysis of ascites
Time frame: 12 months
Incidence of the other complications of liver cirrhosis during follow-up
complications of liver cirrhosis : SBP, HE, gastrointestinal bleeding and hepatorenal syndrome
Time frame: 12 months
Patient hospitalizations during follow-up
number of days of hospitalization during 12 months of follow-up
Time frame: 12 months
Quantitative variations of IL-6 in serum between day 1 and day 30
Dosage of IL-6 in serum at D1 and D30
Time frame: 1 month
Quantitative variations of lipopolysaccharides (LPS) in serum between day 1 and day 30
Dosage of LPS in serum at D1 and D30
Time frame: 1 month
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Hôpital Jean Verdier
Bondy, France
CHU Caen
Caen, France
Hôpital Beaujon
Clichy, France
CHIC de Créteil
Créteil, France
CHU Grenoble
La Tronche, France
CHRU de Lille
Lille, France
Hopital de la croix-rousse
Lyon, France
...and 8 more locations
Quantitative variations of copeptin in serum between day 1 and day 30
Dosage of copeptin in serum at D1 and D30
Time frame: 1 month
Quantitative variations of CRP in serum between day 1 and day 30
Dosage of CRP in serum at D1 and D30
Time frame: 1 month
Quantitative variations of von Willebrand Factor antigen in serum between day 1 and day 30
Dosage of von Willebrand Factor antigen in serum at D1 and D30
Time frame: 1 month
Composition of the intestinal microbiota
analyzis of microbiota (quantity and quality of main bacterial strains) in 25 patients from arms A and B at day 1, and at months 3, 6, 12 and 18
Time frame: up to 18 months
Safety analysis of the study drug
Record of adverse events and serious adverse events in each arm
Time frame: 12 months