6 results
Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…
To assess if short antibiotic treatment (3x24 hours) with an anti-pseudomonal carbapenem (imipenem-cilastatin or meropenem) is safe (NON-INFERIOR) with regard to treatment failure in comparison with extended treatment (at least 9x24hours) of high-…
To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.
Main objective: Proportion of subjects who remain treatment-free.Secondary objectives: - Change from Baseline in Patient Reported Outcomes (PROs) (PROMISPF, EQ-5D-5L)- Safety: Total number of subjects in the safety analysis set with any AEcollected…
Objectives:To evaluate the following in NSCLC patients with EGFR or HER2 exon 20 insertion mutations (includingduplication mutations) who are treated with poziotinib:Primary Objective:Objective Response Rate (ORR)Secondary Objectives:• Disease…
Primary ObjectivesTo assess the effects of pexidartinib on the PK parameters of single-dose midazolam and tolbutamide in patients.Secondary ObjectivesTo evaluate:- To determine the overall response rate (ORR) in patients with TGCT,kit-mutant…