TCTR20230526003尚未招募4 期
Accuracy of Two Novel Tuberculosis-specific Skin Tests in Diagnosing Tuberculosis Infection
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 305
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.1.1. For microbiologically-confirmed TB participants
- •1)Male or female subject aged 18-65 years or older.
- •2)Medically diagnosed with TB within the last 6 months (confirmed through cultures and/or molecular testing) and undergoing treatment with anti-tuberculosis agents.
- •3)Capable of comprehending (speaking, reading, and/or writing) Thai.
- •4)Capable of attending all study visits according to the study schedule.
- •5)Willing to provide written inform consent before any study procedures.
- •1.1.2. For participants with low risk of TB-infection
- •1)Male or female subject aged 18-65 years or older.
- •2)No history of contracting TB or contact with patients infected with TB.
- •3)Capable of comprehending (speaking, reading, and/or writing) Thai.
- •4)Capable of attending all study visits according to the study schedule.
- •5)Willing to provide written inform consent before any study procedures.
- •1.1.3. For participants with high risk of TB-infection
- •1)Male or female subject aged 18-65 years or older.
- •2)Living with pulmonary TB positive patients, in contact with TB positive patients >120 hours/month, or in contact with TB positive patients >8 hours in a single sitting.
- •3)Capable of comprehending (speaking, reading, and/or writing) Thai.
- •4)Capable of attending all study visits according to the study schedule.
- •5)Willing to provide written inform consent before any study procedures.
排除标准
- •For microbiologically-confirmed TB participants
- •1)Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment).
- •2)TST at least 12 months prior to enrolling in the clinical trial
- •3)Pregnant or lactating (for biological female subjects)
- •4)History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results).
- •1.2.2. For participants with low risk of TB-infection
- •1)Has a history of TB infection, manifestation of, or thoracic X-ray with TB-related symptoms.
- •2)Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment).
- •3)TST at least 12 months prior to enrolling in the clinical trial.
- •4)Pregnant or lactating (for biological female subjects).
- •5)History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results).
- •1.2.3. For participants with high risk of TB-infection
- •1)Had a history of TB infection or manifestation of TB-related symptoms.
- •2)Immunodeficient; chemotherapy or immunosuppressant medication use within a year of screening (excludes HIV positive patients with CD4 more than 200 cells/mm3 and viral suppression at least 6 months prior to screening and enrollment).
- •3)TST at least 12 months prior to enrolling in the clinical trial.
- •4)Pregnant or lactating (for biological female subjects).
- •5)History of skin disease(s), tattoos, or scarring in regions where the device(s) will be administered (potentially hindering their efficacy and interpretations of results).
研究者
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