Clinical Trial Search

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

Primary: Change in log10 Colony Forming Units (CFU) Per (/) Milliliter (mL) of Direct Respiratory Sputum Samples From Baseline to Day 14 — -0.199; -0.017; -0.092; -0.092…

Primary: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases — 23; 64 Participants

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

Primary: Number of Participants With Culture Negative Status by 8 Weeks — 70; 122 Participants — p=<0.001

Primary: Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) — 38…

Primary: Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group. — 12; 8; 67; 73 participants

Primary: Incidence of Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) Through Follow up Until 26 Weeks After the End of Treatment — 41; 40; 41; 37 Participants

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

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: Stage 1: Change From Baseline in TB Bacterial Load in Sputum as a Measure of Early Bactericidal Activity (EBA) — -1.93; -2.12; -2.08; -1.69 sputum log10CFU/mL

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: 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: TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3…

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: 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: Mean Change From Baseline in QTcF — 12.3; 8.6; 20.7 milliseconds (ms)

Primary: Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System — 4.878; 5.182; 4.046; 5.194 percentage…

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

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

Primary: Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18…

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

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

Primary: Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C — 217; 121; 117; 5 Participants

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

Primary: Average Change Per Day (Slope) of Log Colony Forming Units (CFU) Counts From Day 0 to Day 14 (BACFU [0-14]) to Assess Bactericidal Activity — -0.039; -0.086; -0.065…

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: Proportion of Treatment Failure (Unfavorable Outcome), Defined as Bacteriologic Failure or Relapse or Clinical Failure (Derived) Through Follow-up Until 6 Months After…

Primary: Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation — 78; 73; 84; 92 Participants — p=0.46

Primary: Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication — 6; 3 participants — p=>.05