Phase 2 N=40 Adjunctive Linezolid for the Treatment of Tuberculous Meningitis
Tuberculosis, Meningeal
Primary: Drug Clearance (CL/F) — 6.24 L/hr
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=588 The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
MDR-TB
Primary: STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76) — 0; 133; 162; 122 Participants
Phase 2 N=35 Metronidazole for Pulmonary Tuberculosis (South Korea)
Tuberculosis · Multi-Drug Resistant Tuberculosis
Primary: Changes in TB Lesion Sizes Using High Resolution Computed Tomography (HRCT). — 8.11; 10.08; 6.64; 7.24 reader score
Phase 2 N=96 Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Tuberculosis · AIDS-related Complex
Primary: Sputum Conversion — 36; 60; 36 percentage of participants
Early Phase 1 N=17 Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung
Healthy · Latent Tuberculosis Infection (LTBI)
Primary: Median Difference in CD4 Cell Response to Intrabronchial Instillation of Tuberculin Purified Protein Derivative (PPD) — 5.26; 0.725; 29.9; 2.92 % Antigen Specific T…
Phase 2 N=207 TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
Tuberculosis
Primary: The Time to Sputum Culture Conversion at Week 8 (Stage 1) — 51; NA Days — p=0.0034
Phase 3 N=364 Treatment of Latent TB Infection for Jailed Persons
Tuberculosis
Primary: Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication — 6; 3 participants — p=>.05
Phase 3 N=394 Tuberculosis Treatment Shortening Trial
Tuberculosis
Primary: Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat — 13; 3 Participants
Phase 2 N=85 Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
Pulmonary Tuberculosis
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…
Phase 2 N=70 Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
Tuberculosis
Primary: Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) — 0.98; 0.98; 0.96; 0.95 Percentage — p=<0.001
N/A N=231 Lumbar Puncture and Syphilis Outcome
Syphilis
Primary: Appropriate Decline in Serum Rapid Plasma Reagin Test (RPR) Titer — 38; 30 Participants — p=0.29
Phase 3 N=2,516 TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
Tuberculosis
Primary: TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3…
Phase 2 N=68 Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (TMC207-CL001)
Pulmonary Tuberculosis
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…
Phase 2 N=69 Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
Pulmonary Tuberculosis
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…
Phase 2 N=69 Essentiality of INH in TB Therapy
Tuberculosis
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…
N/A N=490 Tuberculosis Research of INA-RESPOND On Drug Resistance
Lung Tuberculosis · MDR TB
Primary: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases — 23; 64 Participants
Phase 3 N=8,053 Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
Tuberculosis
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…
Phase 2 N=41 Linezolid to Treat Extensively-Drug Resistant Tuberculosis
Pulmonary Tuberculosis · Multidrug Resistant Tuberculosis · Extensively Drug Resistant Tuberculosis
Primary: Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months. — 15; 7 participants
Phase 2 N=76 An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
Tuberculosis
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…
Phase 2 N=180 Trial of High-Dose Rifampin in Patients With TB
Tuberculosis
Primary: Steady State Pharmacokinetic Exposure of RIF — 115.6988; 201.9725; 284.4278 Ratio
Phase 2 N=105 Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
Pulmonary Tuberculosis
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)…
Phase 2 N=37 Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Tuberculosis
Primary: Number of Subjects With Solicited Local Symptoms — 20; 6; 1; 1 Subjects
Phase 2 N=93 Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis
Pulmonary Tuberculosis
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…
Phase 2 N=146 Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Tuberculosis
Primary: Proportion of Patients With Sterile Sputum Cultures — 59; 45 Participants
Phase 2 N=144 Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Tuberculosis
Primary: Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10 — 13; 13; 14; 13 participants
Phase 2 N=481 A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
Tuberculosis, Pulmonary · Tuberculosis, Multidrug Resistant · Extensively Drug-Resistant Tuberculosis
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…
Phase 2 N=69 PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
Pulmonary Tuberculosis
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)…
Phase 2 N=60 Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
Pulmonary Tuberculosis
Primary: Number of Adverse Events — 5; 4; 10; 8 participants
Phase 3 N=181 Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
Tuberculosis, Pulmonary · Tuberculosis, Multidrug-Resistant · Tuberculosis, MDR
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
Phase 2 N=84 Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis
Tuberculosis · HIV Infections
Primary: Mean Change From Baseline in QTcF — 12.3; 8.6; 20.7 milliseconds (ms)