373 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…
To examine the effect of BCG vaccination on the composition and function of the bone marrow.
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…
The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…
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…
Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
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 main objective is to assess target attainment of cefotaxime levels in the critically ill treated with either continuously or intermittently dosed cefotaxime. Secondary objectives are: to develop a predictive mathematical pharmacokinetic (PK)…
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 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 ObjectivesThe primary objectives are to evaluate in infants who are hospitalized with RSV infection:• the pharmacokinetics of JNJ-53718678 after multiple oral doses;• the safety and tolerability of JNJ-53718678 when administered for 7 days.…
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.
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…