Clinical trials: LTBI
HIV Infections, Tuberculosis Infection
European Pregnancy and Paediatric Infections Cohort Collaboration: Paediatric Protocol
Across Europe and worldwide, there are many studies following groups (cohorts) of children living with human immunodeficiency virus (HIV) and other infections over time, to monitor their long-term health.
- Conditions
- HIV Infections, Tuberculosis Infection, Hepatitis C, Covid19
- Trial name
- EPPICC (NCT04677842)
- Testing
- ART Therapy
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- PENTA Foundation
Latent Tuberculosis Infection
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients.
- Trial name
- NCT05746611
- Testing
- Recombinant Mycobacterium tuberculosis fusion protein for injection, TB-PPD was injected
- Where
- China
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above
This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above.
- Trial name
- NCT07152639
- Testing
- 5μg/ml EEC, 5 unit（U） EC, 5 IU TB-PPD
- Where
- 8 sites in China
- Volunteers
- 1,784 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Latent Tuberculosis, Active Tuberculosis
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments
Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not have a general practitioner (GP) registration and their only interaction with the NHS is via Accident and Emergency (A\&E) Departments of…
- Trial name
- ACE (NCT02512484)
- Testing
- venepuncture, sputum collection, xray
- Where
- 3 sites in United Kingdom
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Public Health England
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
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
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Tuberculosis Infection
A Phase II Study of H56:IC31 in Healthy Adolescents
This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents.
- Trial name
- A-043 (NCT03265977)
- Testing
- H56:IC31
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aeras
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
TB - Tuberculosis, Household Contact
Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
The WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly…
- Conditions
- TB - Tuberculosis, Household Contact, HIV, Children, Only
- Trial name
- NCT06511180
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- The Aurum Institute NPC
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
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
TB - Tuberculosis, PTLD
Intergrated Service Delivery for Lung Health Conditions
The Advancing Lung Health in Zambia project aims to improve access to integrated screening, diagnosis, and management of tuberculosis (TB) and other priority respiratory diseases at community and primary healthcare levels.
- Conditions
- TB - Tuberculosis, PTLD, COPD (Chronic Obstructive Pulmonary Disease), Computer Aided Diagnosis
- Trial name
- TB REACH W11 (NCT07816523)
- Testing
- Intergrated lung health screening, AI-Enabled Cough Sound Screening for Tuberculosis, Post-TB Lung Disease evaluation
- Where
- Zambia
- Volunteers
- 20,300 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
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 Infection, Tuberculosis
BCG Revaccination in Children and Adolescents
Bacille Calmette Guerin (BCG) vaccine is one of the most used vaccines of the world, to reduce the risks of natural tuberculous infection.
- Trial name
- BRiC (NCT05330884)
- Testing
- BCG vaccine, Oral Chemoprophylaxis
- Where
- India
- Volunteers
- 9,200 people, healthy volunteers welcome
- Sponsor
- Tuberculosis Research Centre, India
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, Latent Tuberculosis Infection
VDOT for Monitoring Adherence to LTBI Treatment
The three-month short-course treatment with isoniazid [H] and rifapentine [P] (3HP) recently recommended by the Centers for Disease Control and Prevention could dramatically increase the number of persons starting and completing…
- Trial name
- VMALT (NCT02641106)
- Testing
- Video Directly Observed Therapy, In-Person DOT
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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
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)
Tuberculosis
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus…
- Trial name
- NCT04152161
- Testing
- BCG vaccine SSI
- Where
- 5 sites in South Africa
- Volunteers
- 1,836 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute