Clinical trials: Active Tuberculosis
Tuberculosis
A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management
Tuberculosis (TB) is a significant infectious disease worldwide, with millions of people infected and major impact on mortality and public health.
- Trial name
- TB-SPECTRUM (NCT07735754)
- Volunteers
- 940 people, healthy volunteers welcome
- Sponsor
- Irene Latorre Rueda
Tuberculosis, Pulmonary
ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
The purpose of this study is to evaluate the safety and explore the immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in the Bacillus Calmette-Guérin…
- Trial name
- NCT06714513
- Testing
- QTP101
- Where
- 4 sites in South Korea
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Tuberculosis, Human Immunodeficiency Virus
Evaluating Accuracy, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons
Background: In Botswana, as in the rest of sub-Saharan Africa, undiagnosed TB or TB diagnosed late in the course of disease is thought to be the most common cause of death among HIV-infected persons.
- Trial name
- XPRES (NCT02538952)
- Testing
- Xpert device, Intensified TB Case Finding (ICF)
- Where
- Botswana
- Volunteers
- 18,696 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Tuberculosis, Chronic Obstructive Pulmonary Disease
Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis
Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization towards a distinct phenotype associated with…
- Trial name
- NCT02021747
- Where
- Qatar
- Volunteers
- healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
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
Tuberculosis
Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection
This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.
- Trial name
- NextGen (NCT02512939)
- Testing
- blood test, not yet marketed, no trade name
- Where
- 5 sites in United Kingdom
- Volunteers
- 675 people, healthy volunteers welcome
- Sponsor
- University College, London
Tuberculosis
Clinical Study of BCG Vaccine for Intradermal Injection
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design. In this trial, 160 subjects were enrolled.
- Trial name
- NCT04563273
- Testing
- BCG vaccine 1（0.025mg/0.1ml/person）, BCG vaccine 2 （0.05mg/0.1ml/person）, BCG vaccine 3（0.075mg/0.1ml/person）
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Feasibility and Effectiveness of Community Based Isoniazid Preventive Therapy in Kenya
Isoniazid preventive therapy (IPT) is a well studied clinical intervention for primary and secondary prevention of active tuberculosis (TB) after infection with Mycobacterium tuberculosis.
- Trial name
- IPT (NCT00850915)
- Testing
- community IPT
- Where
- 18 sites in Kenya
- Volunteers
- 1,259 people, healthy volunteers welcome
- Sponsor
- KNCV Tuberculosis Foundation
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)
Multidrug Resistant Tuberculosis
MDR-TB Close Contacts Tracing in China (TCCT Study)
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.
- Trial name
- NCT04484129
- Where
- 8 sites in China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Huashan Hospital
Tuberculosis
BCG Vaccination Delivered Intradermally, Orally and by Combined Routes
This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both methods produces greater results.
- Trial name
- NCT00396370
- Testing
- BCG strain Connaught, BCG strain Danish
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Early Risk Assessment in Household Contacts (≥10 Years) of TB Patients by New Diagnostic Tests in 3 African Countries
The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves.
- Trial name
- ERASE-TB (NCT04781257)
- Testing
- New test candidates
- Where
- 3 sites in Mozambique, Tanzania and 1 more
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
Tuberculosis
BCG Revaccination Study in Diabetic and Non-Diabetic Adults
The purpose of this study is to: 1. explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection. 2.
- Trial name
- NCT06246851
- Testing
- BCG Danish
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine
The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers.
- Trial name
- NCT00800670
- Testing
- Ad5Ag85A
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- McMaster University
Latent Tuberculosis Infection
Screening for Latent Tuberculosis in Healthcare Workers With Quantiferon-Gold Assay: A Cost-Effectiveness Analysis
The ministry of health in Israel requires all health-care workers to undergo screening for latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux skin test, which is notoriously unreliable.
- Trial name
- NCT00449345
- Testing
- Blood test for Quantiferon-GOLD assay
- Where
- Israel
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Assuta Hospital Systems
Tuberculosis, Pulmonary
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBTZ169 in Multiple Dosing
This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in Switzerland.
- Trial name
- NCT03776500
- Testing
- PBTZ169
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Innovative Medicines for Tuberculosis
Tuberculosis
Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.
This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety…
- Trial name
- NCT06305104
- Testing
- 2.5μg/ml EEC, 5μg/ml EEC, 5 unit（U） EC
- Where
- 6 sites in China
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Tuberculosis
A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults
70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose (N=30) regimen, or placebo (N=10).
- Trial name
- C-013-404 (NCT02420444)
- Testing
- BCG SSI, AERAS-404
- Where
- Switzerland
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis, HIV
Evaluation of the Effect of 3HP vs Periodic 3HP vs 6H in HIV-Positive Individuals
This study is a parallel, two part, open label, individually randomized, pragmatic trial among HIV-positive individuals. Part A compares a single round of weekly high dose rifapentine plus isoniazid for three months (3HP) to six…
- Trial name
- WHIP3TB (NCT02980016)
- Testing
- rifapentine + isoniazid, Isoniazid
- Where
- South Africa
- Volunteers
- 4,027 people, healthy volunteers welcome
- Sponsor
- The Aurum Institute NPC
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA