Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
This study design is based on a longitudinal observational setting using the same methods for patients in the different groups – LTBI, active TB disease, and a healthy control group (no LTBI but expos
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
16 Years to 94 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/11/2023: 1. Provision of informed consent 2. Aged 16 years or older 3. Engagement with the Leicester Clinical TB service with either suspected TB or as a recent contact of active TB disease 4. Healthy controls with no evidence of active TB disease or LTBI _____ Previous inclusion criteria: 1. Provision of informed consent 2. Aged 18 to 84 years 3. Engagement with the Leicester Clinical TB Service with either suspected active TB disease or as a recent contact of active TB disease 4. Healthy controls will be recruited from the same cohort after investigations have identified no evidence for active TB disease or LTBI
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 02/11/2023: 1. Any chronic medical disorder that, in the opinion of the investigator, may either put the subject at risk (because of participating in the study) or may influence the results of the study or the subject's ability to participate in the study. 2. Donation of blood >450 ml within 3 months of study commencement or during the study (other than for study purposes). 3. Pregnancy or lactation. 4. Participation in an interventional clinical study in the 3 months prior to Visit 1 or participation in a study using interventional medicinal products in the previous 6 months. 5. Proven immunosuppression, including diagnosed immunodeficiency disorders and treatment with immunosuppressive medication, including oral corticosteroids at any dose. 6. Previous chemotherapy for LTBI in the last 5 years. 7. Previous treatment for active TB disease in the last 2 years. _____ Previous exclusion criteria: 1. History of any acute infection in the previous 4-6 weeks 2. Any chronic medical disorder that, in the opinion of the investigator, may either put the subject at risk (because of participating in the study) or may influence the results of the study or the subject's ability to participate in the study. 3. Donation of blood > 450 ml within 3 months of study commencement or during the study (other than for study purposes). 4. Pregnancy or lactation. 5. Participation in an interventional clinical study in the 3 months prior to Visit 1 or participation in a study using interventional medicinal products in the previous 6 months. 6. Proven immunosuppression, including diagnosed immunodeficiency disorders and treatment with immunosuppressive medication, including oral corticosteroids at any dose. 7. Previous chemotherapy for LTBI. 8. Previous treatment for active TB disease. 9. Aged 85 years or over
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early immune response in the airway of patients with latent TB infection is determined using cellular and transcriptional profiling (flow cytometry and RNA sequencing) at baseline and 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early immune response in the airway of patients with Active TB infection and LTBI progressors are determined using the cellular and transcriptional profiling at baseline. 2. Longitudinal changes in immune response in latent TB infection is determined by assessing changes in the transcriptional gene signatures (bioinformatics analyses to identify signatures from RNA seq data) over 2 years. 3. Comparison of blood and airway transcriptional profiles (RNA sequencing) in active TB and latent TB infection. | — |
Countries
United Kingdom
Contacts
Public ContactJee Whang Kim
Outcome results
None listed