Clinical trials: LTBI
Tuberculosis Infection
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or…
- Trial name
- TIPI (NCT04453293)
- Testing
- BCG (Tokyo 172) vaccine
- Where
- 7 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
TB - Tuberculosis
Start Taking Action for Tuberculosis in Kids
Start4Kids: Evaluating the performance, feasibility, acceptability and cost effectiveness of computer-aided detection (CAD) of chest X-ray (CXR) and concurrent testing using novel diagnostics and non-sputum specimens for…
- Trial name
- Start4Kids (NCT07248423)
- Testing
- Xpert MTB/RIF Ultra, Truenat, MTB, Truenat MTB Plus
- Volunteers
- 7,920 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Tuberculosis (TB), Tuberculosis Infection, Latent
Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau
This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting.
- Conditions
- Tuberculosis (TB), Tuberculosis Infection, Latent, Pregnancy, Tuberculosis Diagnosis
- Trial name
- TIPP (NCT07419568)
- Testing
- Enhanced protocol
- Where
- Guinea-Bissau
- Volunteers
- 720 people, healthy volunteers welcome
- Sponsor
- Aarhus University Hospital
Tuberculosis
Study of Pre-clearance of Latent Tuberculosis Infection And BCG Revaccination
The purpose of this research is to further study the tuberculosis (TB) vaccine, Bacillus Calmette Guérin (BCG). The goal of this study is to evaluate whether the BCG vaccine is more effective in preventing TB in adults if it is…
- Trial name
- NCT01119521
- Testing
- BCG strain Danish, Isoniazid
- Where
- South Africa
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Infection
Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis
Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China.
- Trial name
- NCT04148053
- Testing
- TB-antigen responsive T cell markers
- Where
- China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Tongji University
Tuberculosis, Monitoring, Immunologic
T Cell Interferon-gamma Release Assay (TIGRA) in Immunocompromised Individuals
Until recently, the tuberculin skin test (TST) was the only available diagnostic assay for detection of latent infection with M. tuberculosis (LTBI).
- Trial name
- TBNET-TIPS (NCT00707317)
- Where
- 21 sites in Australia, Bulgaria and 12 more
- Volunteers
- 1,843 people, healthy volunteers welcome
- Sponsor
- Tuberculosis Network European Trialsgroup
Latent Tuberculosis
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
- Trial name
- NCT02454738
- Testing
- Ultralow dose chest CT scan
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Tuberculosis
A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 (C-011-404)
This Phase I study will be conducted as a randomized, placebo-controlled, double-blind, dose-escalation study in four groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of…
- Trial name
- C-011-404 (NCT02109874)
- Testing
- AERAS-404 (mcg H4/nmol IC31), Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl
- Where
- South Africa
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Aeras
TB - Tuberculosis
Start4All SCREEN-TB PROTOCOL
Tuberculosis (TB) remains the leading cause of death from a single infectious agent globally, with millions of people still undiagnosed or diagnosed late.
- Trial name
- SCREEN-TB (NCT07517471)
- Testing
- Near point of care (NPOC) NAATs, Low-complexity nucleic acid amplification tests (LC-NAATs), LC-NAAT using pooled testing
- Volunteers
- 37,000 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Healthy Volunteers
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
Background: Human immunodeficiency virus (HIV) is treated with antiretroviral drugs. Many people with HIV also have the lung infection tuberculosis (TB). Most TB treatments are complicated.
- Trial name
- NCT03510468
- Testing
- Tenofovir alafenamide, Rifapentine, Isoniazid (INH)
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Latent Tuberculosis Infection
Vitamin A Supplementation for Modulation of Mycobacterium Tuberculosis Immune Responses in Latent Tuberculosis
In populations with high prevalence of latent tuberculosis infection (LTBI), malnutrition (PEM) may influence incident rates of TB.
- Trial name
- NCT00558480
- Testing
- Vitamin A
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medical Research Council Unit, The Gambia
Active Tuberculosis, Latent Tuberculosis Infection
Performance Evaluation of the VIDAS TB-IGRA Assay.
This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection.
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Trial name
- NCT04048018
- Testing
- Blood draw and IGRA test
- Where
- 24 sites in United States, Brazil and 7 more
- Volunteers
- 2,401 people, healthy volunteers welcome
- Sponsor
- BioMérieux
Compliance, Patient
Treatment of Latent Tuberculosis in Socially Marginalised Citizens
An open-label, randomised controlled trial comparing compliance to treatment for latent tuberculosis infection in socially marginalised citizens.
- Trial name
- DOT-LTBI (NCT03266991)
- Testing
- Rifapentine, Isoniazid
- Where
- 2 sites in Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Aarhus University Hospital
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
Latent Tuberculosis, Human Immunodeficiency Virus
Doravirine, Rifapentine and Isoniazid Interaction
Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex.
- Conditions
- Latent Tuberculosis, Human Immunodeficiency Virus, Rifamycins Causing Adverse Effects in Therapeutic Use, Drug Interaction Potentiation
- Trial name
- DORIIS (NCT03886701)
- Testing
- Doravirine (DOR), Rifapentine (RPT), Isoniazid (INH)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Walter K. Kraft
Tuberculosis, Tuberculosis, Pulmonary
Effect of Integrating Traditional Tuberculosis Care With Modern Health Care on Case Detection
Although many interventions are implemented to increase TB case detection, decrease diagnosis delay, and avoid catastrophic costs, there are no significant changes and the end TB goal will not be achieved in 2035.
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis Infection
- Trial name
- NCT05236452
- Testing
- Training for traditional and modern care providers
- Where
- Ethiopia
- Volunteers
- 918 people, healthy volunteers welcome
- Sponsor
- Bahir Dar University
Tuberculosis
Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis
Mycobacterium Vaccae for Injection (Trade Name "Vaccae") is a kind of bio-products developed by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,and got "The New Drug Certificate "in 1999.
- Trial name
- NCT01979900
- Testing
- Vaccae
- Where
- 4 sites in China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis Infection
Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy
In vitro and in vivo data show promising results of adjunctive use of Chloroquine to standard tuberculosis therapy as Chloroquine enhances animicrobial effectiveness against intracellular MTB.
- Trial name
- NCT05443178
- Testing
- Nivaquine ® (Chloroquine)
- Where
- Switzerland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Tuberculosis Infection
Tuberculosis In Children Visiting Friends and Relatives
In countries with a low incidence of Tuberculosis (TB), the incidence remains higher among the immigrant population than among the autochthonous population beyond the first years after arrival in the host country.
- Trial name
- NCT04236765
- Testing
- TB infection-screening benefiting group
- Where
- Spain
- Volunteers
- 492 people, healthy volunteers welcome
- Sponsor
- Hospital Mutua de Terrassa