<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484129</url>
  </required_header>
  <id_info>
    <org_study_id>KY2020-806</org_study_id>
    <nct_id>NCT04484129</nct_id>
  </id_info>
  <brief_title>MDR-TB Close Contacts Tracing in China (TCCT Study)</brief_title>
  <official_title>Multidrug Resistant Tuberculosis Close Contacts Tracing in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huashan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the incidence of etiologically confirmed or clinically diagnosed active&#xD;
      tuberculosis in close contacts of MDR-TB patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective observational cohort study. MDR-TB patients from multi-centers in&#xD;
      China were continuously evaluated one by one, their close contacts were screened for&#xD;
      elibgility. All subjects were followed for the same length of time: 80 weeks after&#xD;
      enrollment. The symptoms and signs of tuberculosis were followed up to monitor the occurrence&#xD;
      of tuberculosis.&#xD;
&#xD;
      The primary objective is to investigate the incidence of etiologically confirmed or&#xD;
      clinically diagnosed active TUBERCULOSIS in close contacts of MDR-TB patients.&#xD;
&#xD;
      The secondary objective is to assess latent TB infection rates in close contacts of MDR-TB&#xD;
      patients; evaluate the high risk factors of TUBERCULOSIS in close contact population; assess&#xD;
      the loss rate of close contacts within 80 weeks; assess the 80-week mortality rate among&#xD;
      close contacts; isolate the mycobacterium tuberculosis from all patients with active&#xD;
      tuberculosis and analyze drug resistance to evaluate the homology and drug-resistant&#xD;
      transmission pattern of Mycobacterium tuberculosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 21, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Confirmed cases of active tuberculosis</measure>
    <time_frame>80 weeks after enter the group</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical diagnosis of active tuberculosis</measure>
    <time_frame>80 weeks after enter the group</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of latent tuberculosis infection</measure>
    <time_frame>at enrollment</time_frame>
    <description>Incidence of latent tuberculosis infection at enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors associated with TB development</measure>
    <time_frame>80 weeks after enter the group</time_frame>
    <description>Risk factors associated with TB development among the close contact population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance of follow-up</measure>
    <time_frame>80 weeks after enter the group</time_frame>
    <description>number of participants who complete the follow-up schedule</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison the Mycobacteria tuberculosis strains between index patients and their contacts</measure>
    <time_frame>80 weeks after enter the group</time_frame>
    <description>All Mycobacteria tuberculosis strains from index patients ans close contacts will be analyzed to explore the transmission pattern</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Multidrug Resistant Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Close contacts of MDR-TB patients</arm_group_label>
    <description>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 &quot;face-to-face&quot; 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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population enrolled in this study is close contact of patients with MDR-TB&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The index patient:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        1.18-70 years old; 2.Has smear-positive pulmonary tuberculosis with initial laboratory&#xD;
        results with resistance to rifampicin confirmed by GeneXpert; 3.Have an identifiable&#xD;
        address and stay in the area during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Combined extrapulmonary tuberculosis;&#xD;
&#xD;
          2. HIV antibody positive and AIDS patients;&#xD;
&#xD;
          3. Critically ill patients, and according to the judgment of the research physician, it&#xD;
             is impossible to survive for more than 4 months.&#xD;
&#xD;
        Termination/termination criteria:&#xD;
&#xD;
          1. The patient requests to withdraw from the visit;&#xD;
&#xD;
          2. Misdiagnosis and error.&#xD;
&#xD;
        The close contacts:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing to participate in trial treatment and follow-up and can give informed consent;&#xD;
&#xD;
          2. Willing to carry out HIV testing;&#xD;
&#xD;
          3. More than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the&#xD;
             index case.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with active tuberculosis confirmed clinically or etiologically;&#xD;
&#xD;
          2. Mental illness and severe neurosis;&#xD;
&#xD;
          3. The researchers determined that there were any ineligible conditions.&#xD;
&#xD;
        Termination/termination criteria:&#xD;
&#xD;
          1. The patient requests to withdraw from the visit;&#xD;
&#xD;
          2. Find a violation of inclusion or exclusion criteria during treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenhong Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qiaoling Ruan, Dr.</last_name>
    <phone>(086)13661856002</phone>
    <email>ruan_qiao_ling@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Third People's Hospital of Shenzhen City</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangzhou</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Guofang Deng</last_name>
      <phone>86+13530027001</phone>
      <email>lalaliy@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guiyang Public Health Treatment Center</name>
      <address>
        <city>Guizhou</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Cui Cai</last_name>
      <phone>86+13885078936</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Hospital of Infectious Diseases</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yu Chen</last_name>
      <phone>86+15936200217</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangxi Public Health Center</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xinya Yuan</last_name>
      <phone>86+13870963101</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wenhong Zhang, PhD,MD</last_name>
      <phone>+86 21 52889999</phone>
      <phone_ext>8123</phone_ext>
      <email>zhangwenhong@fudan.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Qiaoling Ruan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lingyun Shao</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Qingluan Yang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Feng Sun</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang Li</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chest Hospitalof Xinjiang Uygur Autonomous Region of PRC</name>
      <address>
        <city>Ürümqi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wenlong Guan</last_name>
      <phone>86+13899866660</phone>
      <email>18999918582@189.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hangzhou Red Cross Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Qingshan Cai</last_name>
      <phone>86+13867429139</phone>
      <email>caiqs66@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Central Hospital of Wenzhou City</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiangao Jiang</last_name>
      <phone>86+13676788085</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Wen-hong Zhang</investigator_full_name>
    <investigator_title>Director of Division of Infectious Diseases</investigator_title>
  </responsible_party>
  <keyword>Multidrug Resistant Tuberculosis</keyword>
  <keyword>latent tuberculosis</keyword>
  <keyword>close contacts</keyword>
  <keyword>transmission</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Multidrug-Resistant</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484129
org study id: KY2020-806
nct id: NCT04484129
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Confirmed cases of active tuberculosis
time frame: 80 weeks after enter the group
description: 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.
measure: Clinical diagnosis of active tuberculosis
time frame: 80 weeks after enter the group
description: 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.
measure: Incidence of latent tuberculosis infection
time frame: at enrollment
description: Incidence of latent tuberculosis infection at enrollment
measure: Risk factors associated with TB development
time frame: 80 weeks after enter the group
description: Risk factors associated with TB development among the close contact population
measure: Compliance of follow-up
time frame: 80 weeks after enter the group
description: number of participants who complete the follow-up schedule
measure: Comparison the Mycobacteria tuberculosis strains between index patients and their contacts
time frame: 80 weeks after enter the group
description: All Mycobacteria tuberculosis strains from index patients ans close contacts will be analyzed to explore the transmission pattern
arm group label: Close contacts of MDR-TB patients
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wenhong Zhang, PhD
role: Principal Investigator
affiliation: Huashan Hospital
last name: Qiaoling Ruan, Dr.
phone: (086)13661856002
email: ruan_qiao_ling@163.com
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country: China
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Wen-hong Zhang
investigator title: Director of Division of Infectious Diseases
mesh term: Tuberculosis
mesh term: Tuberculosis, Multidrug-Resistant