Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-07-21
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Close contacts of MDR-TB patients
Close contacts of MDR-TB who met the inclusion and exclusion criteria were enrolled. Routine follow-up is scheduled at week 8, 20, 32, and 80. During the visit, participants with suspected tuberculosis symptoms will have detailed clincial assessent, weight measurement, sputum smear, sputum culture and drug sensitivity examination, imaging examinations, etc. For patients diagnosed with TB, the trial ends. Proper treatment will be started. For all paricipants who are not diagnosed with tuebrculosis in previous follow-up, the last follow-up of this study is all "face-to-face" visits. Sputum smear, sputum culture and chest imaging screening will be performed when necessary to exclude the possibility of tuberculosis infection. In addition, If the participants has suspected TB symptoms or is diagnosed with TB in another hospital, the researchers can be contacted for follow-up at any time.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Willing to participate in trial treatment and follow-up and can give informed consent;
2. Willing to carry out HIV testing;
3. More than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the index case.
Exclusion Criteria
2. HIV antibody positive and AIDS patients;
3. 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:
1. The patient requests to withdraw from the visit;
2. Misdiagnosis and error.
The close contacts:
1. Patients with active tuberculosis confirmed clinically or etiologically;
2. Mental illness and severe neurosis;
3. The researchers determined that there were any ineligible conditions.
Termination/termination criteria:
1. The patient requests to withdraw from the visit;
18 Years
70 Years
ALL
Yes
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Wen-hong Zhang
Director of Division of Infectious Diseases
Principal Investigators
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Wenhong Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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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
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
Countries
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Central Contacts
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Facility Contacts
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Cui Cai
Role: primary
Yu Chen
Role: primary
Xinya Yuan
Role: primary
Xiangao Jiang
Role: primary
Other Identifiers
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KY2020-806
Identifier Type: -
Identifier Source: org_study_id
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