ISRCTN17985576
Active, not recruiting
未知
Investigating early immunological EVENTs in active TB disease and latent TB infection (EVENT TB)
niversity of Leicester0 sites200 target enrollmentSeptember 10, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Tuberculosis
- Sponsor
- niversity of Leicester
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •Current exclusion criteria as of 02/11/2023:
- •1\. Any chronic medical disorder which, 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 subjects’ ability to participate in the study.
- •2\. Donation of blood \>450ml 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 of 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 year.
- •7\. Previous treatment for active TB disease in the last 2 year.
- •Previous exclusion criteria:
- •1\. History of any acute infection in the previous 4\-6 weeks
Outcomes
Primary Outcomes
Not specified
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