22 results
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 main objective is to evaluate pharmacokinetics of a maximum standard dose (2000mg) of ertapenem in TB patients.
Primary Objective: The primary objective of this prospective clinical trial is to determine the pharmacokinetic variability of SXT (960 mg) in patients receiving TB treatment. With these pharmacokinetic parameters, a population model and limited…
The primary objective of the study is to evaluate the effects of orally administered metformin on the immune and metabolic responses of stimulated peripheral blood mononuclear cells (PBMC*s) and macrophages from healthy individuals.
Primary Objective: The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose of 600 and 800 mg MFX. Secondary Objectives: * To evaluate limited…
Primary:The primary objective is to evaluate the safety profile of an adjuvated Tb subunit vaccine (CAF01) administered in 50 µg Ag85B-Esat-6 alone, 50 µg Ag85B-Esat-6 alone with three escalating CAF01 dose levels, to four groups of healthy…
1. Monitoring of cellular (T-cel) specifc immune response in bladder and bloodsamples after intravesical BCG- therapy. 2. Monitoring and comparing T-cell responses after BCG therapy in patients with clinical BCG-related complications to the T-…
The objective of this study is to validate drug concentration measurement using DBS by comparing the results of blood samples routinely withdrawn from venous blood versus withdrawn by finger prick and transferred to filter paper to make dried blood…
Primary objective is to characterize the anti-mycobacterial immune responses during vaccination with live-attenuated M. Bovis BCG Danish strain 1331, in order to provide a framework for using biomarkers in future TB vaccine trials. Secondary…
To describe the steady state pharmacokinetics of rifampicin, desacetylrifampicin, ethambutol, claritromycin, 14alpha-OH clarithromycine and azithromycin in plasma of adult patients with NTM infections in the Netherlands
1. The central hypothesis of this study is that genetic polymorphisms in drug metabolising enzymes and regulators of enzyme expression may predispose to ATDH. We propose to evaluate the presence of genetic polymorphisms among TB patients in…
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
Primary objective:- To evaluate dose modifications of the new Kaletra Meltrex tablets (lopi-navir/ritonavir 200/50 mg) when combined with rifampicin in healthy volunteersSecondary objectives:- To evaluate the safety of combined use of the new…
Primary objective:The primary objective is to evaluate the safety of an adjuvated TB subunit vaccine administered in PPD positive volunteers at 0 and 2 months.Secondary objective:The secondary objective is to determine the immunogenicity profile of…
Primary Objectives: To explore whether QFT-plus is equipped to differentiate between active TB disease and latent TB infectionTo explore a possible correlation between QFT-plus response and time after TB-infection and/or diagnosis tuberculosis /…
Primary Objectives:1. To determine the proportion of patients with any of various predefined lesions suggestive of old TB infection detected by ULDCT in patients with LTBI as defined by TST or IGRA result, but without any LTBI-lesions on CXR2. To…
The primary objective is to describe the pharmacokinetics of a 5-day dosing period of minocycline in patients with NTM disease.The secondary objective is to evaluate the effect of rifampicin on the pharmacokinetics of a 5-day dosing period of…
To determine the relationship between tissue immune responses and the clinical course of mycobacterial infections.
The overarching aim of this study is to contribute to dose optimization of CFZ in the treatment of NTM diseases.The primary objective of this study is to describe the PK of CFZ, after 4 weeks of treatment with a loading dose regimen of 300 mg once…
Objectives* The primary aim is to study the kinetics of QFT-G in military personnel with a positive TST result. * Secondary aims are to study the practical feasibility of using QFT-G in the setting of a military hospital.Next to this we wish to…