The key objective of the study is to assess the clinical efficacy of an oral capsule formulation of iclaprim as step-down therapy in comparison with a full course of intravenous (i.v.) treatment with vancomycin in the treatment of complicated skin and skin structure infections (cSSSI). The primary endpoint will be the clinical cure rate at the test-of-cure (TOC) visit. Secondary objectives include bacteriological outcomes as well as safety and tolerability.
This Phase II trial is designed as a multi-centre, double-blind, double-dummy comparative study. Patients suffering from cSSSI receive i.v. vancomycin for the first two days of treatment and are then randomized to either continue to receive i.v. vancomycin or to be switched to oral iclaprim for eight additional days. A total of 60 patients will be randomized for this study.
Paul Hadvary, head of development at Arpida, said: “We consider the oral switch therapy to be an important option addressing an increasing therapeutic need. It allows patients to be sent home earlier, thereby increasing patient comfort, reducing the risk of contracting additional infections and lowering costs for the healthcare system.”