NCT03069131.

Study name	Two strategies of primary prophylaxis of spontaneous bacterial peritonitis in severe cirrhotic patients with ascites (ProPILARifax)
Methods	Randomised, double‐blind (participant, caregiver, investigator, outcomes assessor), parallel assignment, phase 3 trial
Participants	People with cirrhosis and grade 3 ascites or higher, and low ascitic protein (< 15 g/L) and renal or hepatic impairment.
Interventions	Intervention: rifaximin (550 mg 2 times daily, orally administered) Control: placebo (orally administered) Duration of treatment: unknown
Outcomes	All‐cause mortality (3 months, 6 months, 12 months) Adverse events (spontaneous bacterial peritonitis, gastrointestinal bleed, hepatorenal syndrome, hepatic encephalopathy) Quality of life (frequency and duration of hospitalisations) Laboratory parameters (IL‐6, lipopolysaccharides, copeptin, CRP, vWF) Changes in microbiota
Starting date	2018
Contact information	Thierry Thevenot tthevenot@chu‐besancon.fr Tel: +33381668594 Centre Hospitalier Universitaire de Besancon
Notes	Country of origin: France URL: clinicaltrials.gov/ct2/show/NCT03069131 This study is funded by Alfasigma S.p.A, LC2 Pharma Information from the author regarding this trial: "this trial is still ongoing" received 12 April 2021. Last update posted 17 July 2018 with an estimated study completion date of May 2021. Outcome data from this trial, when completed, could be added to future versions of this review.