A multicenter, double-blind, randomized, phase 3 study to compare the safety and efficacy of intravenous CXA 201 and intravenous Levofloxacin in complicated Urinary Tract Infection, including Pyelonephritis
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Last updated:25th Feb 2011
To demonstrate the non-inferiority of CXA-201 versus comparator (levofloxacin) in adult subjects with cUTI (including pyelonephritis) based on the difference in composite microbiological eradication and clinical cure rate in the mMITT population at the test-of-cure (TOC) visit (7 days [� 2 days] after last treatment) (CXA-201 minus comparator [levofloxacin]), using a non inferiority margin of 10%.
|Study start date||2011-02-25|