20 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…
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…
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…
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…
To investigate the safety and tolerability of GSK2556286 after single ascending and repeat oral doses in healthy adult participants.To determine the pharmacokinetics of single and repeat oral doses of GSK2556286 in healthy participants.To assess the…
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…
PrimaryTo evaluate the safety and tolerability of single and multiple doses of TBAJ-587 in healthy participants.SecondaryTo determine the pharmacokinetics (PK) of single and multiple doses of TBAJ-587 and metabolites M2, M3 and M12. To compare the…
The first main objective is to investigate the pharmacokinetic properties of dry powder amikacin at different dosages and compare the peak serum values to a single i.v. dose. The secondary main objective is to assess the local tolerability of dry…
Primary Objective: To evaluate the safety of high-dose rifampicin (35 mg/kg/d) supplemented with standard doses of isoniazid, pyrazinamide, and ethambutol for 8 weeks in adult subjects with pulmonary or extrapulmonary DS-TB belonging to difficult to…
This study has been transitioned to CTIS with ID 2023-509885-39-00 check the CTIS register for the current data. The primary objective is to describe and compare the incidence of hepatotoxicity in standard care and in a regimen with an optimized…
To determine the effect of hypertonic saline inhalation and best supportive care versus best supportive care alone on clinical efficacy measures in patients with nodular-bronchiectatic M. avium complex pulmonary disease, as measured by changes in…
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…
1. To assess whether azithromycin enhances resolution of systemic inflammation in patients with drug susceptible pulmonary TB receiving HRZE treatment. 2. To assess whether azithromycin on top of HRZE treatment in patients with drug susceptible…
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…