6 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…
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…
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
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…