<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/NCT03822156</url>
  </required_header>
  <id_info>
    <org_study_id>UUlsan</org_study_id>
    <secondary_id>KCT0003707</secondary_id>
    <nct_id>NCT03822156</nct_id>
  </id_info>
  <brief_title>Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort</brief_title>
  <official_title>Clinical Analysis of the Patients With Cavitary Pulmonary Tuberculosis and Endobronchial Tuberculosis in the Private-Public Mix Project for Tuberculosis, Ulsan University Hospital Cohort (PPM-UUH Cohort)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulsan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulsan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a retrospective cohort study. The purpose of this study is to investigate&#xD;
      clinical features of the patients with the cavitary pulmonary tuberculosis (TB) and&#xD;
      endobronchial TB from the patients who have been registered in this hospital for treatment&#xD;
      and follow-up, as part of the &quot;PPM Project (Private-Public Mix project) for Korean National&#xD;
      Tuberculosis Control&quot; introduced in Korea since 2007.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cavitary pulmonary tuberculosis (TB) is known to remain its Infectivity for a longer period&#xD;
      of time than the non-cavitary pulmonary TB, which is usually almost inactivated its&#xD;
      infectivity within two weeks after the administration of the anti - TB drugs.&#xD;
&#xD;
      However, there are few studies on this, so it is not known how long the infectivity persists,&#xD;
      whether there is a correlation with the number of cavities or the size of the cavities&#xD;
      between persistence of infectivity.&#xD;
&#xD;
      Meanwhile, endobronchial TB is known also to be highly infectious, unlike simple pulmonary&#xD;
      TB.&#xD;
&#xD;
      It is not known how long infectivity can persist after the administration of anti-TB&#xD;
      medication, and whether there is any difference in persistence of infectivity regarding the&#xD;
      clinical characteristics of endobronchial TB.&#xD;
&#xD;
      In this study, investigators will analyze the retrospective data analysis of UUH-PPM Cohort,&#xD;
      a cohort of PPM project patients in the Ulsan University Hospital (UUH).&#xD;
&#xD;
      The PPM project is a &quot;Private-Public Mix project&quot; for the eradication of tuberculosis from&#xD;
      Korea, which the Korean government and private medical institutions have been conducting&#xD;
      since 2007.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>8 Years</target_duration>
  <primary_outcome>
    <measure>TLSD</measure>
    <time_frame>at baseline</time_frame>
    <description>Treatment of anti-TB medication to Last Smear positive Duration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TLCD</measure>
    <time_frame>at baseline</time_frame>
    <description>Treatment of anti-TB medication to Last Culture positive Duration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ACSD</measure>
    <time_frame>at baseline</time_frame>
    <description>AFB Culture-Smear positive Dissociation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TCV/RLV</measure>
    <time_frame>at baseline</time_frame>
    <description>TCV/RLV (Total Cavity[ies] Volume/Total Lung Volume) on enhance CT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TTV/RLV</measure>
    <time_frame>at baseline</time_frame>
    <description>TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological measure for Tb lesions including cavity size, number</measure>
    <time_frame>at baseline</time_frame>
    <description>analysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) [cavitary pulmonary TB]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission Duration</measure>
    <time_frame>at baseline</time_frame>
    <description>The patients' Hospital admission duration [cavitary pulmonary TB and endobronchial TB]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isolation Duration</measure>
    <time_frame>at baseline</time_frame>
    <description>The patients' isolation duration during hospital admission [cavitary pulmonary TB and endobronchial TB]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoptysis /Bronchial artery embolization (BAE)</measure>
    <time_frame>at baseline</time_frame>
    <description>The patients' history of Hemoptysis /Bronchial artery embolization (BAE) [cavitary pulmonary TB and endobronchial TB]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TB PCR, XPERT</measure>
    <time_frame>at baseline</time_frame>
    <description>The patients' result of TB PCR, XPERT [cavitary pulmonary TB and endobronchial TB]</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Tuberculosis</condition>
  <condition>Tuberculosis, Pulmonary</condition>
  <condition>Cavity</condition>
  <condition>Bronchoscopy</condition>
  <condition>Acid Fast Bacilli Infection</condition>
  <condition>Multi-drug Resistant Tuberculosis</condition>
  <condition>Transmission</condition>
  <condition>Insolation</condition>
  <arm_group>
    <arm_group_label>Cavitary Pulmonary Tuberculosis</arm_group_label>
    <description>The patients who are diagnosed with the cavitary pulmonary tuberculosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endobronchial Tuberculosis</arm_group_label>
    <description>The patients who are diagnosed with the endobronchial tuberculosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation of AFB smear/culture</intervention_name>
    <description>Observation of the patients from group for their AFB smear/culture results</description>
    <arm_group_label>Cavitary Pulmonary Tuberculosis</arm_group_label>
    <arm_group_label>Endobronchial Tuberculosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who have been registered in this hospital for treatment and follow-up, as part&#xD;
        of the &quot;PPM Project (Private-Public Mix project) for Korean National Tuberculosis Control&quot;&#xD;
        introduced in Korea since 2007.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        A. Cavitary Pulmonary TB Group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 years and older&#xD;
&#xD;
          2. The patient who has the cavitary pulmonary TB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 18 years&#xD;
&#xD;
          2. Any Malignant patient&#xD;
&#xD;
          3. Patients with bacterial or viral or fungal pneumonia based on the judgment of the&#xD;
             attending physician&#xD;
&#xD;
          4. Patients who had a history of any pulmonary cystic lesion such as infected bulla,&#xD;
             bullous emphysema&#xD;
&#xD;
          5. Patients who were diagnosed with pulmonary fungal infection or previous its history or&#xD;
             any documented culture of the fungus from a bronchial sample including sputum&#xD;
&#xD;
          6. Patients who were diagnosed with bronchiectasis&#xD;
&#xD;
          7. Patients who were diagnosed with NTM-PD (non-tuberculous mycobacterial pulmonary&#xD;
             disease) or any documented culture of NTM from a bronchial sample including sputum&#xD;
&#xD;
          8. Patients who were diagnosed with connective tissue disease such as Wegener's&#xD;
             granulomatosis, SLE&#xD;
&#xD;
          9. Patients who were diagnosed with TB destroyed lung&#xD;
&#xD;
         10. Patients who were diagnosed with congenital lung disease such as Congenital Cystic&#xD;
             Adenomatoid Malformation (CCAM), pulmonary sequestration&#xD;
&#xD;
         11. Patients who were diagnosed with interstitial lung disease such as&#xD;
             Lymphangioleiomyomatosis (LAM), idiopathic pulmonary fibrosis (IPF)&#xD;
&#xD;
         12. Patients who were diagnosed with culture-negative pulmonary TB&#xD;
&#xD;
         13. Patients who did not take anti-TB medication more than twice a week on average&#xD;
&#xD;
         14. Patients who were diagnosed with sarcoidosis&#xD;
&#xD;
         15. Patients who were diagnosed with paragonimiasis&#xD;
&#xD;
         16. Patients who were diagnosed with pulmonary thromboembolism due to excluding pulmonary&#xD;
             infarction&#xD;
&#xD;
         17. The patient who did not consent&#xD;
&#xD;
         18. Patients who were diagnosed with MDR/XDR TB through AFB culture&#xD;
&#xD;
        B. Endobronchial TB Group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 years and older&#xD;
&#xD;
          2. The patient who has the endobronchial TB through bronchoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 18 years&#xD;
&#xD;
          2. Patient who was not consented&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwang Won Seo, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ulsan University Hospital, 877 Bangeojin Sunwhando-ro</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 23, 2019</last_update_submitted>
  <last_update_submitted_qc>June 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulsan</investigator_affiliation>
    <investigator_full_name>Kwang Won Seo</investigator_full_name>
    <investigator_title>Associate professor, division of pulmonology, dept. of internal medicine</investigator_title>
  </responsible_party>
  <keyword>Cavitary Pulmonary Tuberculosis</keyword>
  <keyword>Acid fast bacilli (AFB)</keyword>
  <keyword>Isolation</keyword>
  <keyword>Endobronchial Tuberculosis</keyword>
  <keyword>Transmission</keyword>
  <keyword>Drug susceptible test (DST)</keyword>
  <keyword>Ant-tuberculous agent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
    <mesh_term>Tuberculosis, Multidrug-Resistant</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03822156
org study id: UUlsan
secondary id: KCT0003707
nct id: NCT03822156
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a retrospective cohort study. The purpose of this study is to investigate
      clinical features of the patients with the cavitary pulmonary tuberculosis (TB) and
      endobronchial TB from the patients who have been registered in this hospital for treatment
      and follow-up, as part of the "PPM Project (Private-Public Mix project) for Korean National
      Tuberculosis Control" introduced in Korea since 2007.
Cavitary pulmonary tuberculosis (TB) is known to remain its Infectivity for a longer period
      of time than the non-cavitary pulmonary TB, which is usually almost inactivated its
      infectivity within two weeks after the administration of the anti - TB drugs.

      However, there are few studies on this, so it is not known how long the infectivity persists,
      whether there is a correlation with the number of cavities or the size of the cavities
      between persistence of infectivity.

      Meanwhile, endobronchial TB is known also to be highly infectious, unlike simple pulmonary
      TB.

      It is not known how long infectivity can persist after the administration of anti-TB
      medication, and whether there is any difference in persistence of infectivity regarding the
      clinical characteristics of endobronchial TB.

      In this study, investigators will analyze the retrospective data analysis of UUH-PPM Cohort,
      a cohort of PPM project patients in the Ulsan University Hospital (UUH).

      The PPM project is a "Private-Public Mix project" for the eradication of tuberculosis from
      Korea, which the Korean government and private medical institutions have been conducting
      since 2007.
observational model: Cohort
time perspective: Prospective
measure: TLSD
time frame: at baseline
description: Treatment of anti-TB medication to Last Smear positive Duration
measure: TLCD
time frame: at baseline
description: Treatment of anti-TB medication to Last Culture positive Duration
measure: ACSD
time frame: at baseline
description: AFB Culture-Smear positive Dissociation
measure: TCV/RLV
time frame: at baseline
description: TCV/RLV (Total Cavity[ies] Volume/Total Lung Volume) on enhance CT
measure: TTV/RLV
time frame: at baseline
description: TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT
measure: Radiological measure for Tb lesions including cavity size, number
time frame: at baseline
description: analysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) [cavitary pulmonary TB]
measure: Admission Duration
time frame: at baseline
description: The patients' Hospital admission duration [cavitary pulmonary TB and endobronchial TB]
measure: Isolation Duration
time frame: at baseline
description: The patients' isolation duration during hospital admission [cavitary pulmonary TB and endobronchial TB]
measure: Hemoptysis /Bronchial artery embolization (BAE)
time frame: at baseline
description: The patients' history of Hemoptysis /Bronchial artery embolization (BAE) [cavitary pulmonary TB and endobronchial TB]
measure: TB PCR, XPERT
time frame: at baseline
description: The patients' result of TB PCR, XPERT [cavitary pulmonary TB and endobronchial TB]
arm group label: Cavitary Pulmonary Tuberculosis
description: The patients who are diagnosed with the cavitary pulmonary tuberculosis
arm group label: Endobronchial Tuberculosis
description: The patients who are diagnosed with the endobronchial tuberculosis
intervention type: Other
intervention name: Observation of AFB smear/culture
description: Observation of the patients from group for their AFB smear/culture results
arm group label: Cavitary Pulmonary Tuberculosis
arm group label: Endobronchial Tuberculosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kwang Won Seo, M.D., Ph.D.
role: Principal Investigator
affiliation: Ulsan University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: University of Ulsan
investigator full name: Kwang Won Seo
investigator title: Associate professor, division of pulmonology, dept. of internal medicine
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
mesh term: Tuberculosis, Multidrug-Resistant
sharing ipd: No