Clinical trials: Mycobacterium Tuberculosis Infection
Tuberculosis, Pulmonary, Mycobacterium Tuberculosis Infection
Clinic-based Versus Hotspot-focused Active TB Case Finding
This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda.
- Trial name
- CHASE-TB (NCT05285202)
- Testing
- Active TB case finding with linkage to preventive therapy (ACF/TPT)
- Where
- Uganda
- Volunteers
- 146,539 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Mycobacterium Tuberculosis, LTBI (Latent TB Infection)
The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population
About 2 billion people worldwide are infected with tuberculosis (TB). Ninety percent of those people have latent TB infection (LTBI).
- Conditions
- Mycobacterium Tuberculosis, LTBI (Latent TB Infection), Malnutrition, Diabetes Mellitus
- Trial name
- NCT04526613
- Where
- India
- Volunteers
- 626 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pulmonary Disease, Tuberculosis, Pulmonary
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to…
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04493671
- Testing
- TBAJ-876 suspension, TBAJ-876 100 mg tablet, TBAJ-876 25 mg tablet
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Mycobacterium Tuberculosis Infection
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants
The trial is designed as a phase III, double-blind, multicenter, randomized, single administration, active-controlled, parallel-group design with two groups of newborn infants receiving either VPM1002 or BCG SII (1:1 allocation)…
- Trial name
- VPM1002 (NCT04351685)
- Testing
- VPM1002, BCG SII
- Where
- 12 sites in Gabon, Kenya and 3 more
- Volunteers
- 6,940 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Tuberculosis, Tuberculosis, Pulmonary
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy…
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory, Lung Diseases
- Trial name
- NCT04874948
- Testing
- 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043
- Where
- Netherlands
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
Pulmonary Disease, Tuberculosis, Pulmonary
A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT05526911
- Testing
- TBAJ-876, Midazolam, Digoxin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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
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
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
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
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
HIV Infections, Mycobacterium Infections
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy. II.
- Conditions
- HIV Infections, Mycobacterium Infections, Tuberculosis
- Trial name
- NCT00004276
- Testing
- thalidomide
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Center for Research Resources (NCRR)