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

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

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

Primary: Time to Sputum Culture Conversion — 5.9; 6.3; 6.1; 6.1 weeks

Primary: Proportion of Patients With Sterile Sputum Cultures — 59; 45 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: Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months. — 15; 7 participants

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

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

Primary: Percentage of Participants Who Achieved Sputum Culture Conversion (SCC) Using the Mycobacteria Growth Indicator Tube (MGIT) System — 45.4; 41.9; 29.6 percentage of…

Primary: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases — 23; 64 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: TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3…

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: Percentage of Participants With Negative Lowenstein Jensen Cultures at Week 8 — 85; 94; 96 percentage of participants w/LJ cx con

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

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

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

Primary: Steady State Pharmacokinetic Exposure of RIF — 115.6988; 201.9725; 284.4278 Ratio

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

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

Primary: Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System — 51; 57 Days — p=0.0562

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: 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: Daily Change in log10 Colony-forming Unit (CFU) — -0.06; -0.18; -0.21; -0.15 log10 CFU per mL sputum per day