Clinical trials: Pulmonary Tuberculosis (TB)
Tuberculosis, Tuberculosis, Pulmonary
A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371
The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of TBA-7371 in healthy subjects
- Trial name
- NCT03199339
- Testing
- TBA-7371
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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 Tuberculosis
Pharmacokinetic Study for Anti-tuberculosis Drugs
The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.
- Trial name
- TBPK (NCT00948077)
- Testing
- Rifater and EMB
- Where
- Taiwan
- Volunteers
- 16 people
- Sponsor
- Taipei Medical University WanFang Hospital
Tuberculosis
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background…
- Trial name
- NCT01131351
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 3 sites in Latvia, Lithuania
- Volunteers
- 10 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, MDR
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance.
- Trial name
- FS-1 (NCT02607449)
- Testing
- FS-1
- Where
- 6 sites in Kazakhstan, Kyrgyzstan
- Volunteers
- 344 people
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
Pulmonary Tuberculosis, Tuberculosis (TB)
Artificial Intelligence-driven Tuberculosis Landscape Analysis & Stratification Research
The goal of this observational study is to establish and validate a comprehensive AI-driven clinical decision support system (AI-CDSS) in whole-chain management for pulmonary tuberculosis (TB) patients.
- Conditions
- Pulmonary Tuberculosis, Tuberculosis (TB), Tuberculosis Active
- Trial name
- TB-ATLAS (NCT07611695)
- Where
- 2 sites in China
- Volunteers
- 31,600 people
- Sponsor
- Huashan Hospital
Pulmonary Tuberculosis
A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)
The purpose of this study is to evaluate the mycobactericidal activity, safety, tolerability, and pharmacokinetics of 6 doses of linezolid: 300 mg once per day, 300 mg twice per day, 600 mg once per day, 600 mg twice per day and…
- Trial name
- NCT02279875
- Testing
- Linezolid, HRZE (isoniazid rifampicin,pyrazinamide,ethambutol)
- Where
- 2 sites in South Africa
- Volunteers
- 113 people
- Sponsor
- Global Alliance for TB Drug Development
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, 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
Pulmonary Tuberculosis
Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed…
- Trial name
- NCT02465216
- Testing
- ID93 + GLA-SE
- Where
- 3 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Access to Advanced Health Institute (AAHI)
TB - Tuberculosis, Silicosis
KAP TB in Senior Management Officials of Companies With Increased Silica Exposure
The study was designed as a descriptive cross-sectional survey conducted between February and October 2022. Senior management officials were targeted because of their role in workplace policy and oversight.
- Conditions
- TB - Tuberculosis, Silicosis, Occupational Exposure, Occupational Health
- Trial name
- KAP TB (NCT07749872)
- Where
- Zambia
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB…
- Conditions
- Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- TB-PRACTECAL (NCT02589782)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 7 sites in Belarus, South Africa and 1 more
- Volunteers
- 552 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Tuberculosis
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
The objective of this study is to evaluate the safety and tolerability of single oral doses of TBA-354 when administered to healthy adult subjects.
- Trial name
- NCT02288481
- Testing
- TBA-354
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, HIV
Nutrition, Diabetes and Pulmonary TB/HIV
We propose a randomised trial among pulmonary TB patients, examined and treated as part of the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in high TB and HIV burden countries.
- Conditions
- Tuberculosis, HIV, Diabetes
- Trial name
- NCT00311298
- Testing
- Multimicronutrients, Energy and proteins
- Where
- Tanzania
- Volunteers
- 1,250 people
- Sponsor
- University of Copenhagen
Tuberculosis, Severe Pneumonia
Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia)
Despite progress in reducing tuberculosis (TB) incidence and mortality in the past 20 years, TB is a top ten cause of death in children under 5 years worldwide.
- Conditions
- Tuberculosis, Severe Pneumonia, Covid19
- Trial name
- NCT03831906
- Testing
- Xpert MTB/RIF Ultra (Ultra)
- Where
- 16 sites in Cambodia, Cameroon and 4 more
- Volunteers
- 2,570 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Tuberculosis
Prevalence of Latent Tuberculosis (TB) Infection Diagnosed by Interferon-gamma Release Assay and Tuberculin Skin Tests in Patients With Old Healed TB
We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma release assay and tuberculin skin tests in…
- Trial name
- NCT01099098
- Where
- South Korea
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
Pulmonary Tuberculosis
A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial.
- Trial name
- NCT00366470
- Testing
- A. 100,000 IU Cholecalciferol per dose of 3.3ml, B. Migliol Oil without Cholecalciferol
- Where
- 2 sites in India
- Volunteers
- 250 people
- Sponsor
- Peter Daley
Tuberculosis
Rapid Diagnosis of Pulmonary Tuberculosis
The purpose of this study is to test whether a saline nebulization (breathing in a mist of moist air through a mask) will help an individual cough up a better sputum sample to test for tuberculosis (TB).
- Trial name
- NCT00608790
- Testing
- Salbutamol, Sodium chloride 5%
- Where
- South Africa
- Volunteers
- 600 people
- Sponsor
- University of Cape Town
Pulmonary TB
Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease
RIFAstrat is a Phase 3, double-blind, placebo-controlled, non-inferiority trial to compare the 6-month standard treatment for DS-TB with a 4-month optimised- rifampicin based regimen provided to individuals with limited disease…
- Trial name
- RIFAstrat (NCT07118696)
- Testing
- Extra 600mg of Rifampicin
- Volunteers
- 1,000 people
- Sponsor
- Hamilton Health Sciences Corporation