6 results
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
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 (…
PRIMARY* To determine the efficacy on study Day 28 of T-Guard in inducing a clinical response in patients with severe acute GVHD refractory to first line steroid therapy.SECONDARY* To evaluate the overall safety and efficacy during the first 6…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
Primary Objective: Assess the ability of MRCP+ and LMS to detect change in total biliary volume and cT1 value, 8 weeks after endoscopic treatment of dominant strictures, by a clinical decision rule.Secondary Objective(s): Comparison of baseline MRCP…