3 results
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The purpose of Part A is to investigate how safe the study compound is and how well the study compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed into and eliminated from the body (this is…
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…