Clinical trials: Mycobacterium Tuberculosis
TUBERCULOSIS, PULMONARY
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
- Trial name
- ISIT-TB (NCT04995406)
- Testing
- ISIT-TB prototype
- Where
- South Africa
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- BioMérieux
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis
PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Bacterial Infections, Mycobacterial Infection
- Trial name
- NCT04783727
- Testing
- Individualised treatment duration based on RNA transcriptomic model
- Where
- 5 sites in Germany, Moldova and 2 more
- Volunteers
- 4 people
- Sponsor
- Research Center Borstel
Tuberculosis, Latent Tuberculosis
Multi-site Cohort Study for the Development of Personalized Pharmacotherapy in Patients With Tuberculosis (TB)
Based on the collected antibiotic concentration data and individual patient's clinical information, a pharmacokinetic analysis report that can be applied for dose adjustment of the individual patient is provided.
- Conditions
- Tuberculosis, Latent Tuberculosis, Nontuberculous Mycobacterium Infection
- Trial name
- NCT05280886
- Testing
- therapeutic drug monitoring(TDM)
- Where
- 3 sites in Indonesia, South Korea
- Volunteers
- 5,000 people
- Sponsor
- Inje University
Mycobacterium Infections, Tuberculosis
Effect of Filarial Infection on Immune Responses in Latent Tuberculosis
Background: Lymphatic filariasis is an infection that is caused by small, thread-like worms. It is spread by mosquitoes, and causes fever, chills, and headaches.
- Conditions
- Mycobacterium Infections, Tuberculosis, Filariasis, Latent Tuberculosis
- Trial name
- NCT01547884
- Where
- 2 sites in United States, India
- Volunteers
- 4,268 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Mycobacterium Tuberculosis, Protection Against, Tuberculosis
ChAdOx1 85A Aerosol Versus Intramuscular Vaccination in Healthy Adults (TB039)
This is a dose escalating and a paired-placebo design study to describe the safety and immunogenicity profile of candidate TB vaccine ChAdOx1 85A given by aerosol inhaled vaccination versus intramuscular (IM) vaccination in adult…
- Trial name
- TB039 (NCT04121494)
- Testing
- ChadOx1 85A - aerosol, ChadOx1 85A - IM
- Where
- Switzerland
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- François Spertini
Healthy
Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac
This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults.
- Trial name
- NCT03878004
- Testing
- GamTBvac vaccine
- Where
- 2 sites in Russia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Mycobacterium Tuberculosis
Immune Responses to Mycobacterium Tuberculosis
This study, conducted at the University of Mali in the capital city of Bamako, will investigate how the body reacts to infection with Mycobacterium tuberculosis (MTB), the organism that causes tuberculosis.
- Trial name
- NCT00340990
- Where
- Mali
- Volunteers
- 111 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Study to Evaluate the Tolerability and Immunogenicity of Nyaditum Resae ® Probiotic Administered to Pediatric Population in Contact With Tuberculosis With or Without Latent Tuberculosis Infection
This is a doble-blind, masked, compared with placebo clinical trial in pediatric population in contact with tuberculosis with or without tuberculosis infection.
- Trial name
- NCT02581579
- Testing
- Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis
- Where
- 3 sites in Spain
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Manresana de Micobacteriologia, SL
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Tuberculosis, Tuberculosis, Pulmonary
A Single Ascending Dose Study of BTZ043
This study is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics of single doses of BTZ043 in healthy adult volunteers.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections, Lung Diseases
- Trial name
- NCT03590600
- Testing
- BTZ-043
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
Mycobacterium Tuberculosis
A Cluster-Randomized Trial of DOTS vs DOTS Plus Active Case Finding
The purpose of the study is to see if one plan for identifying and treating tuberculosis (TB) works better than another in reducing new cases of TB.
- Trial name
- NCT00414882
- Where
- Brazil
- Volunteers
- 200,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Safety and Immunogenicity of Nyaditum Resae® Probiotic to Protect From Tuberculosis
This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers with or without tuberculosis infection.
- Trial name
- NCT02076139
- Testing
- Nyaditum resae® 10e4, Nyaditum resae® 10e5, Distilled water
- Where
- Spain
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Manresana de Micobacteriologia, SL
Tuberculosis, Pulmonary, Mycobacterium Tuberculous
Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali
Background: -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate.
- Conditions
- Tuberculosis, Pulmonary, Mycobacterium Tuberculous, Antitubercular Agents, Tuberculosis, Mulutidrug-Resistant
- Trial name
- NCT01381757
- Where
- 2 sites in United States, Mali
- Volunteers
- 34 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Mycobacterium Tuberculosis
Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine
The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed, distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with rifapentine.
- Trial name
- NCT00460759
- Testing
- Moxifloxacin, Rifapentine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Latent Tuberculosis Infection
Immune Responses to Mycobacterium Tuberculosis (Mtb) in People With Latent Tuberculosis Infection With or Without Concomitant Helminth Infection
Background: Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide. It is caused by a bacteria that enters through the lungs and can spread elsewhere in the body.
- Trial name
- NCT02225158
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hemoptysis, Haemoptysis
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis
The study consist of a retrospective analysis of the etiologies, investigations and outcomes of patients presenting between 2005 to 2010 with hemoptysis in a North-American Tertiary center.
- Conditions
- Hemoptysis, Haemoptysis, Lung Disease, Pneumonia
- Trial name
- NCT02913365
- Where
- Canada
- Volunteers
- 1,000 people
- Sponsor
- Université de Sherbrooke
Acquired Immunodeficiency Syndrome, HIV Infections
Tuberculosis in a Multiethnic Inner City Population
To determine the incidence of tuberculosis in an inner city population, identify risk factors for TB, describe the natural history in adults and children, evaluate the effect of Mycobacterium tuberculosis (Mtb) co-infection on…
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections, Lung Diseases, Tuberculosis
- Trial name
- NCT00005379
- Sponsor
- NYU Langone Health
Tuberculosis, Pulmonary
Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis
OBJECTIVES: I. Compare the pharmacokinetics and early bactericidal activity of paromomycin (aminosidine) vs streptomycin for the treatment of uncomplicated pulmonary tuberculosis. II.
- Trial name
- NCT00004444
- Testing
- paromomycin, streptomycin
- Volunteers
- 24 people
- Sponsor
- FDA Office of Orphan Products Development