4 results
What is the level of agreement between the gold standard, which includes invasive DO2 and VO2 measurements (with pulmonary artery catheter and central venous line), when compared with DO2 and VO2 measurements derived by a minimal invasive approach (…
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…
To evaluate the long-term safety, tolerability and efficacy of ArikaceTM 590 mg for a maximum 12 cycles administered once daily, where each cycle consists of 28 days on treatment followed by 28 days off treatment.
The main goal of the study is to assess the incidence of respiratory events using the IPI device.