N/A N=466 Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Mycobacterium Infections, Atypical
Primary: Bacilli Negative Conversion Rate — 269 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=31 Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
Cystic Fibrosis
Primary: Median Maximal Drug Concentration (Cmax) — 16.56; 12.5; 11.2; 3.0 mg/L
Phase 2 N=66 Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
Mycobacterium Infections, Nontuberculous · Mycobacterium Abscessus Infection · Nontuberculous Mycobacterial Lung Disease
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
Phase 2 N=10 A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection
Nontuberculous Mycobacterium Infection
Primary: Percent Patients With Negative Sputum Culture — 40 percentage of participants
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=32 Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
Mycobacterium Infections, Nontuberculous
Primary: Number of Participants With Sputum Culture Conversion to Negative — 2; 3 Participants
Phase 2 N=89 Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
Mycobacterium Infections, Nontuberculous
Primary: Change in Semi-Quantitative Mycobacterial Culture Results From Baseline to Day 84. — 5; 5; 1; 1 Participants — p=0.072
Phase 3 N=99 Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
Mycobacterium Infections, Nontuberculous
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…
Phase 2 N=29 Trial of Antimycobacterial Therapy in Sarcoidosis
Sarcoidosis
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…
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 3 N=336 Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
Mycobacterium Infections, Nontuberculous
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…
Phase 3 N=129 A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Primary: Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24 — 3; 16 Participants — p==0.002
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=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 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=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 2 N=207 Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
Pulmonary Tuberculosis
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…
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…
Phase 3 N=163 Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
NTM Lung Infection Due to MAC
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 68; 90; 20; 32 participants
Phase 1 N=15 Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis
Pulmonary Sarcoidosis · Lung Function
Primary: Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy. — 2.61 liters
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
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
Phase 2 N=282 High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)
Tuberculosis
Primary: Daily Change in log10 Colony-forming Unit (CFU) — -0.06; -0.18; -0.21; -0.15 log10 CFU per mL sputum per day
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 2 N=233 To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
Tuberculosis
Primary: The Median Time to Sputum Culture Conversion — 57 Days
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)
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=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 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 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