Clinical trials: Active Tuberculosis
Tuberculosis
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
- Trial name
- NCT05203068
- Testing
- Recombinant tuberculosis allergen (RTA)
- Where
- Russia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Tuberculosis
Clinical Concordance Evaluation of T-SPOT®.TB Assay Performance (T-Cell SelectTM Study)
The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select…
- Trial name
- NCT04141982
- Testing
- T-Cell SelectTM Kit
- Where
- 4 sites in United States, South Africa
- Volunteers
- 680 people, healthy volunteers welcome
- Sponsor
- Oxford Immunotec
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
Tuberculosis
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers.
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis).
- Trial name
- NCT00423566
- Testing
- MVA85A (Tuberculosis vaccine)
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers
A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers
- Trial name
- NCT00423839
- Testing
- MVA85A (Tuberculosis vaccine)
- Where
- The Gambia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Multi-drug Resistant Tuberculosis
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
- Trial name
- TB-MR (NCT03057756)
- Testing
- Km+ Mfx+ Pto + H + Cfz +E+Z
- Where
- Gabon
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Tuberculosis
Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent.
- Trial name
- NCT03806699
- Testing
- ID93+GLA-SE
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Tuberculosis
Randomized Clinical Trial: IS Zinc and Zinc Ionophere EGCG as Supplement Improve Outcome of Active Pulmonary Tuberculosis
Tuberculosis is still global burden disease at all the word and effect on quality life of patients and affect on health authorities because the cost of medicine and health cost .
- Trial name
- NCT05116098
- Testing
- zinc 50 mg + Epigallocatechin gallate
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Tuberculosis
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of [14C] PA-824, and (2) the pharmacokinetics, safety, and tolerability of…
- Trial name
- CL-004 (NCT03202693)
- Testing
- PA-824
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis (TB)
Tuberculosis (TB) Aftermath
TB Aftermath will compare effectiveness, cost-effectiveness and feasibility of two ACF strategies for detecting recurrent TB and provide evidence needed to implement and scale the preferred ACF strategy.
- Trial name
- NCT04333485
- Testing
- Home-based Active Case Finding (HACF), Telephonic Active Case Finding (TACF)
- Where
- India
- Volunteers
- 3,094 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
TB
Study of the Safety and Immunogenicity of Bacille Calmette Guerin (BCG) Vaccine
Tuberculosis (TB) kills about three million people annually. It is estimated that one third of the world's population are latently infected with Mycobacterium tuberculosis (M.tb).
- Trial name
- NCT00654316
- Testing
- BCG
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
Leukapheresis Sampling for Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US
The objective of this protocol is to obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after one dose of BCG in BCG-naïve healthy adults.
- Trial name
- NCT02413502
- Testing
- BCG
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis, Diagnoses Disease
Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis
Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection.
- Trial name
- uLAMTBFIA (NCT06306430)
- Testing
- STANDARDTM F TB LAM FIA
- Where
- Italy
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Ospedale San Raffaele
Tuberculosis
Non-invasive TB Triage and Patient Mapping Platform Using Breath Via Low-Cost Titanium Dioxide Nanotube Sensor
The purpose of this pilot study is to evaluate the sensitivity and specificity of a nanotube-based point-of-care breath-based tuberculosis screening test as compared to the current standards of care including sputum microscopy…
- Trial name
- NCT02681445
- Testing
- Breath Collection
- Where
- India
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- University of Utah
HIV Infections, Neonatal Infection
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directionally between maternal and fetal…
- Conditions
- HIV Infections, Neonatal Infection, LTBI - Latent Tuberculosis Infection, Immune Tolerance
- Trial name
- IMMUNEO (NCT03383211)
- Testing
- RNAseq
- Where
- 2 sites in Moldova
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- George Washington University
Tuberculosis
A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A
This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have…
- Trial name
- NCT00653770
- Testing
- FP85A, MVA85A
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Vitamin A Deficiency
Efficacy of Newborn Vitamin A Supplementation in Improving Immune Function
Vitamin A supplementation at birth may increase survival of infants through one year of age by reducing mortality from infectious diseases, though current studies are not conclusive on this point.
- Trial name
- NCT01583972
- Testing
- retinyl palmitate
- Where
- Bangladesh
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- USDA, Western Human Nutrition Research Center
Hiv, Hepatitis B
Delivering a Multi-disease Screening Tool to Migrant Populations
Migrants' overall health status may be improved by increasing the detection of certain infectious diseases and other conditions for which effective care is available.
- Conditions
- Hiv, Hepatitis B, Hepatitis C, Tuberculosis
- Trial name
- ISMiHealth (NCT05868005)
- Testing
- Clinical decision support system for screening of migrants using the ISMiHealth software tool.
- Where
- 2 sites in Spain
- Volunteers
- 980 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
Tuberculosis, Pulmonary
Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden
The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a…
- Trial name
- NCT05190146
- Where
- 36 sites in Bangladesh, Brazil and 12 more
- Volunteers
- 7,203 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute