Clinical trials: Mycobacterium Tuberculosis Infection
Tuberculosis, Extrapulmonary
Same Day Diagnosis of Extrapulmonary TB (TB Serositis and TB Meningitis).
Extrapulmonary TB (EPTB) accounts for nearly 30% of TB cases in HIV endemic settings, such as South Africa. The diagnosis of extrapulmonary TB is complicated by the poor performance of Gene Xpert and TB Culture in extrapulmonary…
- Trial name
- Epi-TB (NCT06135818)
- Testing
- IRISA-TB
- Where
- 4 sites in South Africa, Zambia and 1 more
- Volunteers
- 2,160 people
- Sponsor
- University of Cape Town
Tuberculosis
Study of AERAS 422 in Healthy Adults
The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in healthy, BCG-naïve adults.
- Trial name
- NCT01340820
- Testing
- AERAS-422, BCG Tice
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis, Drug-resistant Tuberculosis
Brief Bactericidal Activity of Anti-Tuberculosis Drugs
The investigators will determine the bactericidal activity of high-dose isoniazid against M. tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at 0.1 and 0.4 mcg/ml or (2) susceptible at 0.4…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Isoniazid Resistant Tuberculosis (Disorder)
- Trial name
- BBA (NCT02236078)
- Testing
- High dose isoniazid
- Where
- India
- Volunteers
- 18 people
- Sponsor
- Centers for Disease Control and Prevention
Recurrent Tuberculosis
Improving Retreatment Success (IMPRESS)
This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB, among patients previously treated for TB.
- Trial name
- IMPRESS (NCT02114684)
- Testing
- moxifloxacin
- Where
- South Africa
- Volunteers
- 197 people
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Tuberculosis
Tuberculosis Vaccine in Healthy Indian Adults
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and…
- Trial name
- BBV169/2023 (NCT06438978)
- Testing
- Tuberculosis Vaccine
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Tuberculous Meningitis
Retrospective Real-word Study of Linezolid for the Treatment of Tuberculous Meningitis
Tuberculous meningitis (TBM) is the most serious form of Mycobacterium tuberculosis infection, causing mortality and disability in more than half of the patients.
- Trial name
- NCT03898635
- Testing
- Linezolid
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Huashan Hospital
Pulmonary Infection, Pulmonary Nodule
Remimazolam for Bronchoscopy in High-Risk Patients
Bronchoscopy is currently widely used for the diagnosis and treatment of various respiratory diseases. However, the operation of bronchoscopy is irritating, causes a strong stress response, and shares the airway with the patient…
- Conditions
- Pulmonary Infection, Pulmonary Nodule, Phthisis, Endotracheal Tumour
- Trial name
- NCT07395596
- Testing
- propofol and alfentanil, remimazolam combined with propofol and alfentanil
- Where
- 2 sites in China
- Volunteers
- 360 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Tuberculosis
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)
The study has the following objectives: Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To…
- Trial name
- THYB-03 (NCT01049282)
- Testing
- Antigen (Ag85B-ESAT-6), Antigen (Ag85B-ESAT-6) with adjuvant (IC31)
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis, Children, Only
Integrating Pediatric TB Services Into Child Healthcare Services in Africa
Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare…
- Conditions
- Tuberculosis, Children, Only, Diagnosis, Delivery of Health Care
- Trial name
- INPUT (NCT03862261)
- Testing
- Integrated pediatric TB services
- Where
- 12 sites in Cameroon, Kenya
- Volunteers
- 1,715 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Tuberculosis, Pulmonary
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
This is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in…
- Trial name
- StatinTB (NCT04147286)
- Testing
- Atorvastatin 40mg
- Where
- South Africa
- Volunteers
- 220 people
- Sponsor
- University of Cape Town
Multidrug-resistant Tuberculosis
Pharmacometric Optimization of Second Line Drugs for MDR Tuberculosis Treatment
Multidrug-resistant (MDR) tuberculosis (TB), defined as simultaneous resistance to isoniazid and rifampin, has been declared a global emergency.
- Trial name
- PODrtb (NCT02727582)
- Where
- 2 sites in South Africa
- Volunteers
- 142 people
- Sponsor
- University of Cape Town
Tuberculosis, Pulmonary
Co-Infection of NTM in Patients With Smear Positive Pulmonary TB
The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB.
- Trial name
- NCT00567151
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Seoul National University Hospital
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
Training Protocol on the Natural History of Tuberculosis
Background: Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.
- Conditions
- Mycobacterium Infections, Tuberculosis, Multidrug-Resistant, Latent Tuberculosis, Tuberculosis
- Trial name
- NCT01212003
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Isolated Mediastinal Lymphadenopathy, Sarcoidosis
A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)
Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a variety of different causes. In the past an operation (mediastinoscopy) was required to diagnose the glands.
- Conditions
- Isolated Mediastinal Lymphadenopathy, Sarcoidosis, Tuberculosis, Lung Cancer
- Trial name
- REMEDY (NCT00932854)
- Testing
- EBUS
- Where
- United Kingdom
- Volunteers
- 75 people
- Sponsor
- University College London Hospitals
Tuberculosis, Tuberculosis Infection
Testing Health Workers At Risk to Advance Our Understanding of TB Infection
It has been estimated that 1.7 billion people have tuberculosis (TB) infection; yet current tests are unable to predict which people are at highest risk of developing TB disease, which can be life-threatening.
- Trial name
- THWART-TB (NCT06221488)
- Testing
- TB infection testing
- Where
- South Africa
- Volunteers
- 300 people
- Sponsor
- Beth Israel Deaconess Medical Center
Tuberculosis, Latent Tuberculosis
Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection
The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test (Mantoux Tuberculin Skin Test (TST)), for…
- Trial name
- PREDICT (NCT01162265)
- Where
- 3 sites in United Kingdom
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Public Health England
Cystic Fibrosis
Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination.
- Trial name
- CIMENT (NCT03312075)
- Testing
- Sputum and blood samples
- Where
- 14 sites in France
- Volunteers
- 848 people
- Sponsor
- University Hospital, Brest
Tuberculosis
A Blinded, Cross-sectional, Diagnostic Evaluation Study Performed in Pulmonary TB Suspects at the TB Dispensary for Sector 4 of the Marius-Nasta-Institute in Bucharest, Romania
The diagnosis of tuberculosis (TB) and especially the detection of drug resistance of tuberculosis mycobacteria can be time consuming and costly.
- Trial name
- NCT02382107
- Testing
- Observational
- Where
- Romania
- Volunteers
- 400 people
- Sponsor
- Michael Hoelscher
HIV, Tuberculosis
Tuberculosis and Human Immunodeficiency Virus (HIV) Immune Reconstitution Syndrome Trial (THIRST)
The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess…
- Trial name
- THIRST (NCT00851630)
- Testing
- Fixed dose combination zidovudine/lamivudine/abacavir
- Where
- Tanzania
- Volunteers
- 70 people
- Sponsor
- Duke University
Tuberculosis
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route
This is a phase I study that will compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been…
- Trial name
- NCT01181856
- Testing
- MVA 85A
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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