Effect of Mycobacterial Infection on Immune Status
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This study, titled "Effect of Mycobacterial Infection on Immune Status" (EMIIS), investigates the immune-driven mechanisms of mycobacterial infections, focusing on the dynamic immune characteristics of multidrug-resistant tuberculosis (MDR-TB), nontuberculous mycobacterial (NTM) infections, and tuberculous pleurisy. Mycobacterial infections (including the Mycobacterium tuberculosis complex and nontuberculous mycobacteria) remain a major global public health threat. EMIIS is a single-center, randomized, single-blind,prospective study. The study recruited 120 participants, divided into groups of healthy individuals/community-acquired pneumonia patients, active pulmonary tuberculosis patients, latent tuberculosis infection patients, tuberculous pleurisy patients, and nontuberculous mycobacteria patients. Blood samples were collected from all groups within 3 days before treatment and 2-3 months after treatment. Pleural effusion samples were additionally collected from the tuberculous pleurisy group within 3 days before treatment and 2 months after treatment. Exhaled breath condensate (EBC) was collected from the nontuberculous mycobacteria group. Utilizing mass cytometry (CyTOF) and multi-dimensional indicators, the study aims to elucidate the immune-driven mechanisms of mycobacterial infections and provide new strategies for individualized treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Inclusion Criteria：
- •Age ≥ 18 years, all genders and races accepted.
- •Patients with active pulmonary tuberculosis diagnosed clinically or by bronchoscopy within less than 1 week.
- •Patients with latent tuberculosis infection (positive T-SPOT test but no evidence of active tuberculosis infection).
- •Patients with tuberculous pleurisy with onset within less than 1 week.
- •Voluntarily join this study and sign the informed consent form.
- •Patients whose drug susceptibility test or NGS results indicate resistance to at least isoniazid and rifampicin (MDR-TB).
- •Patients whose drug susceptibility test or NGS results indicate sensitivity to first-line anti-tuberculosis drugs.
- •Patients whose drug susceptibility test or NGS results indicate resistance to only one anti-tuberculosis drug.
- •Patients with newly identified nontuberculous mycobacterial infection (within less than 1 week) by sputum culture or NGS.
- •Exclusion Criteria：
- •Immunosuppressive conditions including HIV infection, long-term use (>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.
- •Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.
- •Patients with diabetes mellitus.
- •Pregnant or lactating women.
- •Patients unable or unwilling to provide informed consent, or with poor compliance.
研究者
Chao Cao, Ph.D.
Principal Investigator
First Affiliated Hospital of Ningbo University