Clinical Trial Search

Primary: Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24 — 3; 16 Participants — p==0.002

Primary: Number of Participants Achieving Culture Conversion by Month 6 in the Liposomal Amikacin for Inhalation (LAI) + Multi-drug Regimen (MDR) Arm Compared to the MDR Alone…

Primary: Bacilli Negative Conversion Rate — 269 participants

Primary: Change in Semi-Quantitative Mycobacterial Culture Results From Baseline to Day 84. — 5; 5; 1; 1 Participants — p=0.072

Primary: Number of Participants With Sputum Culture Conversion to Negative — 2; 3 Participants

Primary: Median Maximal Drug Concentration (Cmax) — 16.56; 12.5; 11.2; 3.0 mg/L

Primary: Percentage of Participants With Clinical Response on NTM Symptom Assessment Scale at Day 84 — 34.1; 20.0 Percentage of participants — p=0.2182

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 68; 90; 20; 32 participants

Primary: Percent Patients With Negative Sputum Culture — 40 percentage of participants

Primary: STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) — 0; 133; 162; 122 Participants

Primary: Changes in TB Lesion Sizes Using High Resolution Computed Tomography (HRCT). — 8.11; 10.08; 6.64; 7.24 reader score

Primary: Psychometric Cross-Sectional Validation of Patient Reported Outcome (PRO): Patient Global Impression of Severity (PGI-S) Respiratory Scale Score at Baseline — 2.5; 2.4…

Primary: Proportion of Patients With Sterile Sputum Cultures — 59; 45 Participants

Primary: Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time…

Primary: Juniper Asthma Control Questionnaire (ACQ) Results — -0.15; -0.38 units on a scale

Primary: Change in Lesion Size at the Completion of Antibiotic Therapy, Measured on a Continuous Scale; Change Will be Determined by Change in Diameter of the Lesions — -8.4…

Primary: The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. — 0.133…

Primary: The Time to Sputum Culture Conversion at Week 8 (Stage 1) — 51; NA Days — p=0.0034

Primary: Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media — 48; 63; 66; 55 days

Primary: Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) — 0.98; 0.98; 0.96; 0.95 Percentage — p=<0.001

Primary: Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14 — 0.134; 0.096; 0.136; 0.119…

Primary: Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time…

Primary: Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months. — 15; 7 participants

Primary: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) — 5; 19 participants

Primary: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture — 2; 3 Participants

Primary: Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14)…

Primary: Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat — 13; 3 Participants

Primary: Sputum Conversion — 36; 60; 36 percentage of participants

Primary: The Median Time to Sputum Culture Conversion — 57 Days

Primary: Change in P. Aeruginosa Density — 0.23; -0.31; -0.31; -0.73 log10 CFU/g sputum — p=0.0014