Expression of Tuberculosis in the Lung
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline)
研究概览
简要总结
The purpose of this study is to assess lung immune responses in patients with active pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium tuberculosis in households of patients with TB or who are unexposed.
详细描述
BACKGROUND:
M. tuberculosis infects a third of the world's population, and TB is the leading cause of morbidity and mortality due to a single infectious agent. However, only 5% to 10% of M. tuberculosis-infected subjects without an underlying immunodeficiency develop disease during their lifetimes. Therefore protective immunity is induced in the majority of subjects. Understanding correlates of protection against M. tuberculosis in humans is needed to better direct efforts in the development of antituberculosis vaccines.
DESIGN NARRATIVE:
Patients are treated according to good clinical practice; however, no study medications are given as part of the research study. This study involves a one-time bronchoalveolar lavage and venipuncture to obtain immune cells for laboratory studies of immune responses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TB patients who are 18 to 65 years old
- •Clinical and radiographic signs and symptoms consistent with pulmonary TB
- •Start date of antituberculous chemotherapy less than 10 days prior to procedures
- •Sputum smear positive for acid fast bacilli
- •Drug-sensitive, culture-confirmed growth of M. tuberculosis from sputum
- •Willing to provide informed consent for participation in bronchoalveolar lavage and venipuncture studies
排除标准
- •TB patients who have HIV-1 coinfection
- •History of any chronic medical condition requiring daily medication (including diabetes mellitus, hypertension, chronic infections, renal or cardiac failure, and peptic ulcer disease)
- •History of asthma or upper or lower respiratory tract infection within 2 months of the study
- •Hemoglobin level less than 10g/dl
结局指标
主要结局
Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline)
时间窗: one week
次要结局
未报告次要终点