To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.
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.
Study Type
OBSERVATIONAL
Enrollment
500
The Third People's Hospital of Shenzhen City
Shenzhen, Guangzhou, China
Guiyang Public Health Treatment Center
Guizhou, Guizhou, China
Henan Hospital of Infectious Diseases
Zhengzhou, Henan, China
Jiangxi Public Health Center
Nanchang, Jiangxi, China
Confirmed cases of active tuberculosis
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.
Time frame: 80 weeks after enter the group
Clinical diagnosis of active tuberculosis
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.
Time frame: 80 weeks after enter the group
Incidence of latent tuberculosis infection
Incidence of latent tuberculosis infection at enrollment
Time frame: at enrollment
Risk factors associated with TB development
Risk factors associated with TB development among the close contact population
Time frame: 80 weeks after enter the group
Compliance of follow-up
number of participants who complete the follow-up schedule
Time frame: 80 weeks after enter the group
Comparison the Mycobacteria tuberculosis strains between index patients and their contacts
All Mycobacteria tuberculosis strains from index patients ans close contacts will be analyzed to explore the transmission pattern
Time frame: 80 weeks after enter the group
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Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
Ürümqi, Xinjiang, China
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang, China
The Central Hospital of Wenzhou City
Wenzhou, Zhejiang, China