20 completed, 3 unknown, 2 withdrawn, 1 recruiting. 27 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 27 | Completed 20, Unknown 3, Withdrawn 2, Recruiting 1, Terminated 1 |
| Phase 2 | 6 | Completed 4, Unknown 1, Withdrawn 1 |
Follow Tuberculosis, Pulmonary: new trials by email Literature Review of Tuberculosis, Pulmonary trials Research Report on Tuberculosis, Pulmonary
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74 QTP101, Placebo - Tuberculosis, Pulmonary | Phase 1 | Recruiting | Quratis Inc. | 144 | 2025-05-09 | 2025-06-17 |
| Azacytidine During Anti-tuberculosis Therapy Azacitidine Injection - Tuberculosis, Pulmonary | Phase 1 / Phase 2 | Withdrawn | Andrew Dinardo | 2022-10-01 | 2023-02-08 | |
| A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults TBAJ-876, Midazolam, Digoxin - Pulmonary Disease, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 28 | 2022-06-30 | 2024-10-08 |
| Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis MetFORMIN 500 Mg Oral Tablet, Placebo - Tuberculosis, Pulmonary | Phase 1 / Phase 2 | Unknown | Mahidol University | 80 | 2022-01-15 | 2022-02-14 |
| Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Michael Hoelscher | 4 | 2021-10-08 | 2024-12-31 |
| Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects TBI-223 1800 mg, TBI-223 2400mg, TBI-223 Placebo - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 28 | 2021-02-03 | 2025-06-05 |
| Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults TBAJ-876 suspension, Placebo suspension, TBAJ-876 100 mg tablet - Pulmonary Disease, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 137 | 2020-06-08 | 2025-06-04 |
| BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) BTZ-043, Rifafour e-275®, Probe Drug Cocktail - Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis | Phase 1 / Phase 2 | Completed | Michael Hoelscher | 78 | 2019-11-15 | 2026-08-31 |
| Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBTZ169 in Multiple Dosing PBTZ169, Placebo - Tuberculosis, Pulmonary | Phase 1 | Completed | Innovative Medicines for Tuberculosis | 32 | 2019-02-21 | 2020-10-22 |
| A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults TBI-223 oral suspension, TBI-223 enteric capsule, TBI-223 SR Tablet Prototype 1 - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 86 | 2019-01-16 | 2024-12-09 |
| A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis 10 mg OPC-167832, 30 mg OPC-167832, 90 mg OPC-167832 - Pulmonary TB | Phase 1 / Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 122 | 2018-10-18 | 2023-11-18 |
| Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults ID93 + GLA-SE - Pulmonary TB | Phase 1 | Completed | Access to Advanced Health Institute (AAHI) | 48 | 2018-10-02 | 2023-06-01 |
| A Single Ascending Dose Study of BTZ043 BTZ-043, Placebo - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Michael Hoelscher | 30 | 2018-06-07 | 2019-03-07 |
| Safety and Immunogenicity Study of GX-70 in TB Patient GX-70 by electroporation - Pulmonary Tuberculoses, High Risk Factors for Relapse | Phase 1 | Withdrawn | Yonsei University | 2018-03-01 | 2019-01-11 | |
| Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Ex-vivo Antitubercular Activity of PBTZ169 Formulation PBTZ169 Formulation, Placebo, PBTZ169 NCP - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Innovative Medicines for Tuberculosis | 32 | 2017-12-05 | 2018-07-13 |
| Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Sutezolid, Placebo - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 32 | 2017-09-26 | 2018-02-08 |
| A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371 TBA-7371, Placebo - Tuberculosis, Tuberculosis, Pulmonary | Phase 1 | Completed | Global Alliance for TB Drug Development | 74 | 2017-08-29 | 2018-10-17 |
| Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB 11C-acetate ligand, FDG ligand - Tuberculosis, Pulmonary | Phase 1 | Unknown | National University Hospital, Singapore | 5 | 2016-11-01 | 2017-04-13 |
| Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts FDG ligand, DOTANOC ligand - Tuberculosis, Pulmonary | Phase 1 | Unknown | National University Hospital, Singapore | 30 | 2016-11-01 | 2016-11-18 |
| A Multiple Ascending Dose Study With a Dose Formulation Comparison Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects TBA-354, TBA-354 Placebo - Tuberculosis | Phase 1 | Terminated | Global Alliance for TB Drug Development | 18 | 2015-11-01 | 2019-09-18 |
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Tuberculosis (20) · Lung Diseases (4) · Acquired Immunodeficiency Syndrome (2) · HIV Infections (2) · Mycobacterium Infections (2) · Tuberculosis, Multidrug-Resistant (2) · AIDS-Related Opportunistic Infections (1) · Bacterial Infections (1) · Gram-Positive Bacterial Infections (1) · Lentivirus Infections (1) · Lung Neoplasms (1) · RNA Virus Infections (1) · Respiratory Tract Infections (1)
Actinomycetales Infections (27) · Bacterial Infections and Mycoses (27) · Infections (27) · Respiratory Tract Diseases (27) · Bacterial Infections (26) · Gram-Positive Bacterial Infections (26) · Respiratory Tract Infections (26) · Mycobacterium Infections (25) · Lung Diseases (23) · Tuberculosis (7) · Blood-Borne Infections (2) · Communicable Diseases (2) · Genital Diseases (2) · Immune System Diseases (2) · Immunologic Deficiency Syndromes (2)
Midazolam (3) · 2-(2-methyl-1,4-dioxa-8-azaspiro(4.5)dec-8-yl)-8-nitro-6-(trifluoromethyl)-4H-1,3-benzothiazin-4-one (2) · Isoniazid (2) · Rifampin (2) · TBA-354 (2) · TBAJ-876 (2) · Tablets (2) · 68Ga-DOTANOC (1) · Azacitidine (1) · Bupropion (1) · Digoxin (1) · Ethambutol (1) · Fluorodeoxyglucose F18 (1) · Interferon-gamma (1) · Levofloxacin (1)
Global Alliance for TB Drug Development (8) · Access to Advanced Health Institute (AAHI) (3) · Michael Hoelscher (3) · Innovative Medicines for Tuberculosis (2) · National University Hospital, Singapore (2) · Andrew Dinardo (1) · Johns Hopkins University (1) · Mahidol University (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Otsuka Pharmaceutical Development & Commercialization, Inc. (1) · Quratis Inc. (1) · SPP Pharmaclon Ltd. (1) · Xijing Hospital (1) · Yonsei University (1)
United States (12) · South Africa (3) · Singapore (2) · Switzerland (2) · Germany (1) · Netherlands (1) · Russia (1) · South Korea (1) · Thailand (1)
Antonio Lombardi, MD (2) · Jerry Nedelman (2) · Nicholas Paton (2) · Andreas Diacon, Prof (1) · Andrew DiNardo (1) · Angelo Del Parigi, MD (1) · Anna Marie Beckmann, PhD (1) · Christopher Fox, PhD (1) · Cohn J (1) · Egorin M (1) · Franco Piazza, MD, MPH (1) · Hafner R (1) · Jae Chol Choi, MD, PhD (1) · Jan Jaap van Lier, MD (1) · Jinhee Lee, DVM, PhD (1)
PMID 40067046, PMID 11401954, PMID 15374844, PMID 21956689, PMID 24614383, PMID 25880846, PMID 29595510, PMID 30210819, PMID 36878897, PMID 39194204, PMID 39612928, PMID 39793592, PMID 41121745, PMID 42568101
272201400041C-0-0-1 (1)