10 results
Step 1 Primary objective: To describe the population pharmacokinetics of flucloxacillin for non-critically ill patients and determine the influence of covariates (demographics and renal function) on the kinetics of flucloxacillin. Step 2Primary…
To determine whether 4 weeks of total antibiotic treatment duration is non-inferior to 6 weeks in patients with complicated SAB who have responded well to the initial treatment.
The primary objective of Study I3Y-MC-JPBM is to compare treatment with LY2835219 plus NSAI therapy versus placebo plus NSAI therapy with respect to PFS in postmenopausal women with HR+, HER2- locoregionally recurrent or metastatic breast cancer who…
The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…
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 (…
The purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…
The primary objective is to determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
Main objective:Part 1: To determine the RP2D of abemaciclib that may be safely administered to patients with mCRPC in combination with abiaterone acetate and prednisone.Part 1&2&3:To compare the rPFS of patients receiving abiraterone…
: Our aim is to evaluate whether the current flucloxacillin absorption test is able to adequately predict the absorption of flucloxacillin compared to an absorption test after switch to oral therapy, and identify co-variants in order to improve the…
The primary objective is To evaluate the efficacy, in terms of invasive disease-free survival (IDFS), as defined by the STEEP System, for patients with HR+, HER2- early stage breast cancer for a dose of abemaciclib twice daily plus adjuvant…