Hall In Tirol

This research focuses on evaluating the use of intravenously administered fosfomycin to treat severely infected patients across Europe. It includes those with serious infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis and central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections as permitted by national guidelines. The study is prospective, multicenter, non-interventional, and aims to document both the effectiveness and safety of this treatment. Patients receive fosfomycin treatment according to the national Summary of Product Characteristics (SmPC) guidelines for fosfomycin intravenous use. The study does not involve comparing treatment groups or altering standard care but observes patients receiving fosfomycin in routine clinical settings. There are no specific dosing schedules or additional interventions imposed by the study protocol. During the study, participants are monitored until the end of treatment, which may last up to six months after starting fosfomycin. Researchers evaluate clinical success by assessing whether patients achieve clinical cure or improvement. Safety and outcomes are recorded through clinical observations, with the goal of better understanding fosfomycin's role in treating severe infections.

Researchers are evaluating the effect of Seladelpar on clinical outcomes in patients with Primary Biliary Cholangitis (PBC) who have compensated cirrhosis. This Phase 3 study focuses on adults with PBC and cirrhosis classified as Child-Pugh (CP) score A or B to better understand how Seladelpar may impact the disease course compared to placebo treatment. Participants will be assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg of Seladelpar once daily, while those with CP-B cirrhosis will take 5 mg once daily. The placebo group will take one capsule daily for the same duration. This randomized, double-blind, placebo-controlled design ensures that the effects of Seladelpar can be assessed rigorously against a control. Throughout the study, participants will be monitored regularly with scheduled assessments to evaluate their health and response to treatment. Researchers will measure Event Free Survival over 36 months as the primary outcome. Safety and liver function will be closely observed through laboratory tests and clinical evaluations. Participants must comply with study requirements and complete all scheduled visits during the treatment period.