ISRCTN17985576进行中（未招募）未知
Investigating early immunological EVENTs in active TB disease and latent TB infection (EVENT TB)
niversity of Leicester0 个研究点目标入组 200 人开始时间: 2021年9月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
- •2. 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.
- •3. Donation of blood > 450ml 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 or over
研究者
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