Clinical trials: 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
HIV/AIDS, Tuberculosis
Targeted Universal TB Testing With Simultaneous TPT Prescribing Among People Living With HIV in South Africa
Background: In 2023, the South African Department of Health introduced targeted universal TB testing (TUTT) at antiretroviral therapy (ART) initiation (irrespective of the presence of TB symptoms).
- Trial name
- TUTT-PT (NCT06739915)
- Testing
- TUTT-PT Intervention
- Where
- South Africa
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Tuberculosis Infection, Latent, Tuberculosis Active
SCAF-TB - Saving Children and Their Families From Tuberculosis: Implementation Research to Improve TB Preventive Treatment Initiation and Completion Rates Among Contact Persons in Tajikistan and Tanzania
The SCAF-TB study aims to evaluate how the WHO-endorsed SIILTIBCY skin test can be best implemented to test close contacts for tuberculosis infection (TBI) in Tajikistan and Tanzania, either facility-based or home-based delivered…
- Conditions
- Tuberculosis Infection, Latent, Tuberculosis Active, TPT
- Trial name
- SCAF-TB (NCT07714707)
- Testing
- CY-TB Patch, Audiblehealth DX
- Where
- 2 sites in Tajikistan, Tanzania
- Volunteers
- 880 people, healthy volunteers welcome
- Sponsor
- KNCV Tuberculosis Foundation
Renal Impairment, Tuberculosis
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including…
- Trial name
- NCT03896750
- Testing
- PA-824
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Tuberculosis (TB)
Shaping a Community-based Pathway to Improve TB Surveillance Among African and Hindustan Immigrants Experiencing Vulnerabilities
This two-phase, mixed-methods approach project aims to develop a community-based, participatory, and co-created TB/TB infection (TBI) screening care pathway for African and Hindustan immigrants, who often face socioeconomic…
- Conditions
- Tuberculosis, Tuberculosis (TB), Tuberculosis Active, Tuberculosis Infection, Latent
- Trial name
- AFROHINDU-MIGT (NCT07687121)
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Universidade Nova de Lisboa
Tuberculosis
Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac
This study is a multicenter, double-blind, randomized, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of the GamTBvac recombinant subunit tuberculosis vaccine for the prevention of active…
- Trial name
- NCT04975737
- Testing
- GamTBvac
- Where
- Russia
- Volunteers
- 9,500 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Tuberculosis, TB Infection
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia
- Trial name
- NCT07647107
- Testing
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose)
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Healthy Volunteers
A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832.
- Trial name
- NCT07542847
- Testing
- OPC-167832, Itraconazole, Carbamazepine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis
Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study.
- Trial name
- NCT05824091
- Testing
- MK-7762 (TBD09)
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Latent Tuberculosis Infection (LTBI)
C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
- Trial name
- C-TST (NCT07587164)
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
- Where
- Indonesia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Multi Drug Resistant Tuberculosis, HIV Infections
An Adaptive Randomized Controlled Trial
This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment…
- Trial name
- ADAP-TIV (NCT05633056)
- Testing
- Adherence support intevention
- Where
- South Africa
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Columbia University
Community Health Nursing Education, Chronic Obstructive Pulmonary Disease
Virtual Reality Cave vs. Simulated Home for Community Nursing Education: A Crossover Trial Comparing Student Competence, Confidence, and Satisfaction
Background and Purpose Community health nursing is essential for providing healthcare to individuals in home and neighborhood settings.
- Conditions
- Community Health Nursing Education, Chronic Obstructive Pulmonary Disease, Pulmonary Tuberculosis
- Trial name
- NCT07595588
- Testing
- VR CAVE Immersive Simulation for Community Health Nursing Education, Traditional Simulated Home Environment for Community Health Nursing Training
- Where
- Hong Kong
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
Tuberculosis, COVID-19
Evaluating the Impact of Computer-assisted X-ray Diagnosis and Other Triage Tools to Optimise Xpert Orientated Community-based Active Case Finding for TB and COVID-19
Tuberculosis (TB) is now the commonest cause of death in many African countries. Globally, ~35% (almost 1 in 3) of TB cases are 'missed' (remain undiagnosed or undetected).
- Conditions
- Tuberculosis, COVID-19, HIV Infections
- Trial name
- NCT05220163
- Testing
- CAD, Xpert
- Where
- 3 sites in South Africa, Zambia and 1 more
- Volunteers
- 26,200 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Intestinal Tuberculosis
A 15-year Cohort Study on Risk Factors of Mortality in Patients With Intestinal Tuberculosis
This study adopts a combined design of retrospective cohort study followed by prospective observational study, which is conducted at Beijing Chest Hospital.
- Trial name
- NCT07575061
- Testing
- Observational
- Where
- China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Beijing Chest Hospital, Capital Medical University
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
Tuberculosis (TB), Human Immunodeficiency Virus (HIV) Prophylaxis
Integrating HIV Prevention With TB Household Contact Evaluation in Uganda
This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care…
- Trial name
- TB PrEP (NCT07119359)
- Testing
- Home-based HIV self-testing, Home-based initiation of PrEP
- Where
- Uganda
- Volunteers
- 2,480 people, healthy volunteers welcome
- Sponsor
- University of Washington
Latent Tuberculosis Infection
Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above
A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other…
- Trial name
- NCT05899179
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein, Purified Protein Derivative of Tuberculin
- Where
- 8 sites in China
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Tuberculosis
A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine…
- Trial name
- NCT06732583
- Testing
- Tuberculosis (TB) vaccine (Ad5-105K), Ad5-105K
- Where
- Indonesia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Tuberculosis
TB Case-Finding, Treatment and Prevention Intervention in Thailand
The project aimed to test a strategy for the early detection and prevention of tuberculosis in household contacts of tuberculosis patients in order to reduce the morbidity, mortality and transmission of this disease in Thailand.
- Trial name
- CaPThai (NCT05581212)
- Testing
- Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack
- Where
- 20 sites in Thailand
- Volunteers
- 7,455 people, healthy volunteers welcome
- Sponsor
- Institut de Recherche pour le Developpement
Tuberculosis (TB)
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and…
- Trial name
- MTBVACph2 (NCT06997367)
- Testing
- MTBVAC, BCG Sii
- Where
- 2 sites in India
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited