Clinical trials: Pulmonary Tuberculosis (TB)
Tuberculosis
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
Pulmonary Tuberculoses, Tuberculosis, Pulmonary
A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress
The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis…
- Trial name
- NCT05477966
- Testing
- Medical records review
- Where
- South Korea
- Volunteers
- 900 people
- Sponsor
- Jae-Joon Yim
TB - Tuberculosis, HIV/AIDS
Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis
The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cause of death in the world.
- Trial name
- TB-LUNG (NCT04700579)
- Where
- 3 sites in South Africa
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- ZeNix (NCT03086486)
- Testing
- Pretomanid, Linezolid, Bedaquiline
- Where
- 11 sites in Georgia, Moldova and 2 more
- Volunteers
- 181 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis (TB), Pulmonary TB
Xpert MTB/RIF Ultra Trial
Tuberculosis (TB) is the leading cause of death caused by infectious agent globally. Estimated 10 million people get ill with TB every year and in 2022 globally there was an increase in Tuberculosis cases, first time since 2010.
- Trial name
- NCT07135622
- Testing
- Xpert® MTB/RIF Ultra, Referral to the specialized TB clinics
- Where
- Georgia
- Volunteers
- 778 people
- Sponsor
- Nestani Tukvadze
Tuberculosis, Pulmonary, Antibiotic Prophylaxis
Prevention of Tuberculosis in Prisons
The purpose of this study is to determine if the isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity of the disease.
- Trial name
- NCT03028129
- Testing
- Isoniazid 900 milligrams
- Where
- Brazil
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- Federal University of Mato Grosso
Tuberculosis (TB)
A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
The goal of this clinical trial is to evaluate if N-acetylcysteine (NAC) works to prevent post-tuberculosis lung disease (PTLD) in patients with severe pulmonary impairment. It also aims to assess the safety of NAC.
- Trial name
- NAC-PTLD (NCT06909799)
- Testing
- N-Acetyl Cysteine (NAC), Standard TB treatment
- Where
- The Gambia
- Volunteers
- 242 people
- Sponsor
- The Aurum Institute NPC
Tuberculosis, Pulmonary
Impact of Malnutrition on Pharmacokinetic of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in TB-HIV Co-infected Children (TB-Speed TB-PK)
TB-Speed TB-PK is a cross-sectional PK study of anti-TB treatment nested in the TB-Speed HIV and TB-Speed SAM studies aiming at assessing the impact of malnutrition on PK of rifampicin, isoniazid, pyrazinamide, and ethambutol in…
- Trial name
- NCT04972903
- Where
- 4 sites in Uganda, Zambia
- Volunteers
- 85 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Tuberculosis
Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine
The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated…
- Trial name
- NCT03017378
- Testing
- TB/FLU-01L
- Where
- Kazakhstan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Research Institute for Biological Safety Problems
Tuberculosis
PK Study of Anti-TB Drugs
This is a prospective descriptive and pharmacokinetic study will be conducted among newly diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border.
- Trial name
- NCT02457208
- Testing
- Isoniazid (H), Rifampicin (R), Pyrazinamide (Z)
- Where
- Thailand
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis, COVID-19
Evaluating the Impact of Computer-assisted X-ray Diagnosis and Other Triage Tools to Optimise Xpert Orientated Community-based Active Case Finding for TB and COVID-19
Tuberculosis (TB) is now the commonest cause of death in many African countries. Globally, ~35% (almost 1 in 3) of TB cases are 'missed' (remain undiagnosed or undetected).
- Conditions
- Tuberculosis, COVID-19, HIV Infections
- Trial name
- NCT05220163
- Testing
- CAD, Xpert
- Where
- 3 sites in South Africa, Zambia and 1 more
- Volunteers
- 26,200 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Tuberculosis, Pulmonary
Comparative Efficacy of CUS, CXR and CAD in TB Diagnosis in LMIC
Pulmonary Tuberculosis (TB) remains a significant global health concern, particularly in low- and middle-income countries (LMIC), where resources for healthcare are often limited.
- Trial name
- CUSTB (NCT06409780)
- Testing
- Comparative analysis of CUS, CAD and CXR in pulmonary TB
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- University of Bari
Tuberculosis, Pulmonary
Drug Exposure and Safety of a Shorter Tuberculosis Treatment Based on High-Dose Rifampicin and Pyrazinamide
Tuberculosis (TB) treatment is long and complex with the risk of poor treatment adherence and treatment failure. Several attempts to shorten treatment of drug-susceptible TB have been unsuccessful.
- Trial name
- HIGHSHORT-RP (NCT04694586)
- Testing
- rifampicin, pyrazinamide, HRZE
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- University Hospital, Linkoeping
Tuberculosis, Pulmonary
Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts
PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog tracers has the potential to provide an imaging technique targeting subclinical granulomatous disease in those with latent tuberculosis…
- Trial name
- NCT02967666
- Testing
- FDG ligand, DOTANOC ligand
- Where
- 2 sites in Singapore
- Volunteers
- 30 people
- Sponsor
- National University Hospital, Singapore
Tuberculosis, Pulmonary, HIV/AIDS
RIPE vs RIPE Plus N-acetylcysteine in Patients With HIV/TB Co-infection
Although tuberculosis is a treatable disease, it is currently the infectious disease with the highest mortality in the world. It is estimated that one-third of the world's population is infected.
- Trial name
- RIPENACTB (NCT03281226)
- Testing
- RIPE (2m) and RI (4m), RIPE+NAC (2m) and RI (4m)
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Pulmonary Tuberculosis (TB)
Immune Reconstitution in Tuberculosis Disease
The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary…
- Trial name
- IRETB (NCT01698476)
- Testing
- vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
- Where
- Ethiopia
- Volunteers
- 390 people
- Sponsor
- Karolinska Institutet
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
The purpose of this is a study to provide early access of TMC207 to patients with pulmonary infection due to strains of Mycobacterium tuberculosis (M.
- Trial name
- NCT01464762
- Testing
- TMC207
- Where
- 5 sites in Lithuania, Russia
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Tuberculosis, Pulmonary
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted at one study center in the United States. Four (4) cohorts of 8 subjects each (6 active and 2 placebo).
- Trial name
- NCT03199313
- Testing
- Sutezolid
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary Tuberculosis
The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)
The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary…
- Trial name
- NCT06476210
- Testing
- BDL regimen
- Where
- 7 sites in China
- Volunteers
- 45 people
- Sponsor
- Beijing Chest Hospital