Multidrug Resistant Tuberculosis Close Contacts Tracing in China
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Confirmed cases of active tuberculosis
研究概览
简要总结
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.
详细描述
This study is a prospective observational cohort study. MDR-TB patients from multi-centers in China were continuously evaluated one by one, their close contacts were screened for elibgility. All subjects were followed for the same length of time: 80 weeks after enrollment. The symptoms and signs of tuberculosis were followed up to monitor the occurrence of tuberculosis.
The primary objective is to investigate the incidence of etiologically confirmed or clinically diagnosed active TUBERCULOSIS in close contacts of MDR-TB patients.
The secondary objective is to assess latent TB infection rates in close contacts of MDR-TB patients; evaluate the high risk factors of TUBERCULOSIS in close contact population; assess the loss rate of close contacts within 80 weeks; assess the 80-week mortality rate among close contacts; isolate the mycobacterium tuberculosis from all patients with active tuberculosis and analyze drug resistance to evaluate the homology and drug-resistant transmission pattern of Mycobacterium tuberculosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.18-70 years old; 2.Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by GeneXpert; 3.Have an identifiable address and stay in the area during the study period.
排除标准
- •Combined extrapulmonary tuberculosis;
- •HIV antibody positive and AIDS patients;
- •Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 4 months.
- •Termination/termination criteria:
- •The patient requests to withdraw from the visit;
- •Misdiagnosis and error.
- •The close contacts:
- •Inclusion Criteria:
- •Willing to participate in trial treatment and follow-up and can give informed consent;
- •Willing to carry out HIV testing;
- •More than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the index case.
- •Exclusion Criteria:
- •Patients with active tuberculosis confirmed clinically or etiologically;
- •Mental illness and severe neurosis;
- •The researchers determined that there were any ineligible conditions.
- •Termination/termination criteria:
- •The patient requests to withdraw from the visit;
- •Find a violation of inclusion or exclusion criteria during treatment.
结局指标
主要结局
Confirmed cases of active tuberculosis
时间窗: 80 weeks after enter the group
Mycobacterium tuberculosis was indicated to be positive by etiology, and the positive ones were confirmed by molecular identification. A false positive may be determined if the investigator determines that the etiological diagnosis is inconsistent with the patient's clinical condition, or that the patient's symptoms, signs, or influence of the medical diagnosis has not responded to treatment.
Clinical diagnosis of active tuberculosis
时间窗: 80 weeks after enter the group
History, signs, imaging studies (mainly chest CT), or other diagnostic methods suggest objective evidence (cough, fever, night sweats, wasting, hemoptysis) for the diagnosis of tuberculosis, rather than other diseases.
次要结局
- Compliance of follow-up(80 weeks after enter the group)
- Comparison the Mycobacteria tuberculosis strains between index patients and their contacts(80 weeks after enter the group)
- Incidence of latent tuberculosis infection(at enrollment)
- Risk factors associated with TB development(80 weeks after enter the group)
研究者
Wen-hong Zhang
Director of Division of Infectious Diseases
Huashan Hospital