200 results
In this study we aim to evaluate the effectivity of the current, standard treatment of uncomplicated urinary tract infections with fosfomycin, based on urine concentrations of fosfomycin in urine in healthy volunteers after receiving a single, oral…
Primary Objective To evaluate long term safety and tolerability of LAI (590 mg) administered once daily (QD) for up to 12 months in subjects who were refractory to standard multi-drug treatment and failed to convert in Study INS-212. Secondary…
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…
PrimaryIn HCV-infected subjects who have previously been treated with MK-5172 and received at least one dose:1. To evaluate the durability of SVR in subjects who remained HCV RNA LLoQ (either TND or TDu) throughout the follow-up period of the…
The primary objective of this study is:- To evaluate the effect of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) on renal parameters at Week 24The secondary objectives of this study are:- To…
Development and prospective validation of a pharmacokinetic model of flucloxacillin for dosing in patients with impaired renal function.
The objective of the current proposal is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and intra-anal high-grade, HPV16 positive AIN, who failed on…
The purpose of the study is to investigate how quickly and to what extent RO7033877 and CMS are getting into your blood stream and how long your body takes to get rid of it (this is called pharmacokinetics) when they are given alone or given at the…
The purpose of the study is to investigate how quickly and to what extent AL-335 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). AL-335 to be administered will be labeled with 14-…
To identify and clone antibodies that can neutralize the bacterial pathogens Escherichia coli and Pseudomonas aeruginosa.
Primary objectiveThe primary objective for this study is to analyse the impact of inhibition of viral replication by interferon-free therapy consisting of Sofosbuvir and Daclatasvir (±Ribavirin) on the phenotype and function of the innate immune…
The purpose of this study is to provide insight in to what extent clinically significant systemic absorption of tobramycin occurs (resulting in a serum tobramycin concentration> 1.0 mg / L) in ICU and Medium Care ICU patients who are being…
To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis.
The aim of this study is to describe the utility of beta-lactam and fluoroquinolone TDM programs in tertiary ICUs. Therefore, the main objective is to document whether empirical antibiotic dosing regimens of these antibiotics achieve defined…
The main objective is to evaluate pharmacokinetics of a maximum standard dose (2000mg) of ertapenem in TB patients.
To investigate whether the current dosing regimen of ciprofloxacin, recommended by the Dutch *Stichting Werkgroep Antibioticabeleid* (SWAB) and applied at the Academic Medical Center for patients with various degrees of renal function admitted at…
To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old
The goal of this study is to document the efficacy of a shortened 8-week therapy with grazoprevir and elbasvir in patients with acute HCV genotype 1 or 4 infection.
Establish the pharmacokinetic parameters of micafungin in critically ill patients and determine whether pharmacokinetic parameters and plasma concentrations of micafungin correlate with disease severity.
The primary objective of this trial is as follows:• To determine the pharmacokinetics of anidulafungin administered to obese patients with a BMI >= 40 kg/m2. The secondary objective of this trial is as follows:• To simulate pharmacokinetics…