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news.Biopharmaceutical company Arpida has received authorization from the FDA to conduct a multi-center, double-blind comparative Phase II intravenous-to-oral switch trial with iclaprim in patients with complicated skin and skin structure infections.
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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 intravenous (IV) 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.
Patients suffering from cSSSI will receive IV vancomycin for the first two days of treatment and will then be randomized to either continue to receive IV vancomycin or be switched to oral iclaprim for eight additional days. A total of 60 patients will be randomized for this study.