36 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…
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…
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…
Determining the impact of freezing PBMC on the test result of the IGRA.
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
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this study is to validate drug concentration measurement using DBS by comparing the results of blood samples routinely withdrawn from venous blood versus withdrawn by finger prick and transferred to filter paper to make dried blood…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…
Enhancement of the sensitivity of the Quantiferon test for patients with an inflammatory disease who are screened for presence of latent tuberculosis infection.
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…
The aim of our study is the development of a simple device that is able to differentiate between sputum from TB patients and non TB patients.With the knowledge and concentration of the VOCs from M. tuberculosis and possible the specific host…
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…
Overall aim: To study the influence of M.leprae antigens on differentiation and maturation of DCs and to identify M.leprae antigens, receptors on antigen presenting cells and signaling pathways which play a role in leprosy pathology. Main objective…
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…