Active substances: Norfloxacin
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The treatment and observational periods are 12 months for both groups. Treatment will not differ between arms.
In order to ensure patient safety, an external data and safety monitoring board DSMB consisting of at least three independent members with a high level of expertise in the conduct of clinical trials, as well as in the fields of hepatology, pharmacology and statistics, will receive unblinded safety and outcome data at defined time points after inclusion of 10, 60 and 100 patients.
Participants In general, all patients with liver cirrhosis and ascites should be screened for the INCA trial.
The most important exclusion criteria are a present SBP or a previous history of such, as well as long-term antibiotic treatment, irrespective of the indication. In this multicenter national study, patients will be recruited at a minimum of 13 participating referral centers.
These centers have specific clinical expertise in treating patients with advanced liver diseases, and ten of them are centers for liver transplantation.