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.

Timeline

Start

2018-06-05

Primary completion

2022-06-03

Completion

2023-03-20

Outcome

Missed primary endpoint

paper RFX did not improve 12-month (PBO vs. RFX: 68.1%, 95% CI 56.2-78.7 vs. 56.6%, 95% CI 43.5-67.8; p = 0.74) PMID 40653111 ↗

Publications

• Thevenot T, Elkrief L, Bureau C, Bardou-Jacquet E, Rosa I, Nguyen-Khac E, Oberti F, Pitta A, Mallet M, Lebosse F, Louvet A, Meunier L, Nahon P, Ollivier-Hourmand I, Anty R, Francoz C, Riachi G, Meunier A, Cervoni JP, Tio G, Muller A, Cure-Martin A, Ladeira R, Clairet AL, Hocquet D, Di Martino V, Weil D, Desmarets M. Effect of rifaximin in patients with severe cirrhosis and ascites: A randomized double-blind placebo-controlled trial. J Hepatol. 2025 Dec;83(6):1320-1327. doi: 10.1016/j.jhep.2025.06.019. Epub 2025 Jul 11.

Drugs

Indications