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MDR-TB Close Contacts Tracing in China (TCCT Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484129
Recruitment Status : Not yet recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

Brief Summary:
To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.

Condition or disease
Multidrug Resistant Tuberculosis

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Incidence of latent tuberculosis infection [ Time Frame: at enrollment ]
    Incidence of latent tuberculosis infection at enrollment

  2. 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

  3. Compliance of follow-up [ Time Frame: 80 weeks after enter the group ]
    number of participants who complete the follow-up schedule

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population enrolled in this study is close contact of patients with MDR-TB
Criteria

The index patient:

Inclusion Criteria:

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.

Exclusion Criteria:

  1. Combined extrapulmonary tuberculosis;
  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:

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:

  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;
  2. Find a violation of inclusion or exclusion criteria during treatment.

Information from the National Library of Medicine

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


Contacts
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Contact: Qiaoling Ruan, Dr. (086)13661856002 ruan_qiao_ling@163.com

Locations
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China, Guangzhou
The Third People's Hospital of Shenzhen City
Shenzhen, Guangzhou, China
Contact: Guofang Deng    86+13530027001    lalaliy@sina.com   
China, Guizhou
Guiyang Public Health Treatment Center
Guizhou, Guizhou, China
Contact: Cui Cai    86+13885078936      
China, Henan
Henan Hospital of Infectious Diseases
Zhengzhou, Henan, China
Contact: Yu Chen    86+15936200217      
China, Jiangxi
Jiangxi Public Health Center
Nanchang, Jiangxi, China
Contact: Xinya Yuan    86+13870963101      
China, Shanghai
Huashan Hospital of Fudan University
Shanghai, Shanghai, China, 200040
Contact: Wenhong Zhang, PhD,MD    +86 21 52889999 ext 8123    zhangwenhong@fudan.edu.cn   
Sub-Investigator: Qiaoling Ruan         
Sub-Investigator: Lingyun Shao         
Sub-Investigator: Qingluan Yang         
Sub-Investigator: Feng Sun         
Sub-Investigator: Yang Li         
China, Xinjiang
Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC
Ürümqi, Xinjiang, China
Contact: Wenlong Guan    86+13899866660    18999918582@189.cn   
China, Zhejiang
Hangzhou Red Cross Hospital
Hangzhou, Zhejiang, China
Contact: Qingshan Cai    86+13867429139    caiqs66@163.com   
The Central Hospital of Wenzhou City
Wenzhou, Zhejiang, China
Contact: Xiangao Jiang    86+13676788085      
Sponsors and Collaborators
Huashan Hospital
Investigators
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Principal Investigator: Wenhong Zhang, PhD Huashan Hospital
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Responsible Party: Wen-hong Zhang, Director of Division of Infectious Diseases, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04484129    
Other Study ID Numbers: KY2020-806
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen-hong Zhang, Huashan Hospital:
Multidrug Resistant Tuberculosis
latent tuberculosis
close contacts
transmission
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections