11 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…
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 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
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…
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…
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…
This study has been transitioned to CTIS with ID 2024-517793-25-00 check the CTIS register for the current data. The primary objective of this study is to investigate the local tolerability of isoniazid inhalation by wet nebulization at ascending…