6 results
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 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…
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…