MDR-TB Close Contacts Tracing in China (TCCT Study)
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|ClinicalTrials.gov Identifier: NCT04484129|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
|Condition or disease|
|Multidrug Resistant Tuberculosis|
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|
|Estimated Enrollment :||500 participants|
|Official Title:||Multidrug Resistant Tuberculosis Close Contacts Tracing in China|
|Estimated Study Start Date :||July 21, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
- Confirmed cases of active tuberculosis [ Time Frame: 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 [ Time Frame: 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.
- Incidence of latent tuberculosis infection [ Time Frame: at enrollment ]Incidence of latent tuberculosis infection at enrollment
- Risk factors associated with TB development [ Time Frame: 80 weeks after enter the group ]Risk factors associated with TB development among the close contact population
- Compliance of follow-up [ Time Frame: 80 weeks after enter the group ]number of participants who complete the follow-up schedule
- Comparison the Mycobacteria tuberculosis strains between index patients and their contacts [ Time Frame: 80 weeks after enter the group ]All Mycobacteria tuberculosis strains from index patients ans close contacts will be analyzed to explore the transmission pattern
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484129
|Contact: Qiaoling Ruan, Dr.||(086)email@example.com|
|The Third People's Hospital of Shenzhen City|
|Shenzhen, Guangzhou, China|
|Contact: Guofang Deng 86+13530027001 firstname.lastname@example.org|
|Guiyang Public Health Treatment Center|
|Guizhou, Guizhou, China|
|Contact: Cui Cai 86+13885078936|
|Henan Hospital of Infectious Diseases|
|Zhengzhou, Henan, China|
|Contact: Yu Chen 86+15936200217|
|Jiangxi Public Health Center|
|Nanchang, Jiangxi, China|
|Contact: Xinya Yuan 86+13870963101|
|Huashan Hospital of Fudan University|
|Shanghai, Shanghai, China, 200040|
|Contact: Wenhong Zhang, PhD,MD +86 21 52889999 ext 8123 email@example.com|
|Sub-Investigator: Qiaoling Ruan|
|Sub-Investigator: Lingyun Shao|
|Sub-Investigator: Qingluan Yang|
|Sub-Investigator: Feng Sun|
|Sub-Investigator: Yang Li|
|Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC|
|Ürümqi, Xinjiang, China|
|Contact: Wenlong Guan 86+13899866660 firstname.lastname@example.org|
|Hangzhou Red Cross Hospital|
|Hangzhou, Zhejiang, China|
|Contact: Qingshan Cai 86+13867429139 email@example.com|
|The Central Hospital of Wenzhou City|
|Wenzhou, Zhejiang, China|
|Contact: Xiangao Jiang 86+13676788085|
|Principal Investigator:||Wenhong Zhang, PhD||Huashan Hospital|