xml: <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/NCT06021041</url>
    </required_header>
    <id_info>
      <org_study_id>RETUBO-S</org_study_id>
      <nct_id>NCT06021041</nct_id>
    </id_info>
    <brief_title>A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients</brief_title>
    <official_title>A Retrospective Study on the Treatment Pattern and Clinical Prognosis of Severe Tuberculosis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <brief_summary>
      <textblock>
        This is a retrospective clinical study to analyze the clinical characteristics,&#xD;
        complications, and effects of different treatment options on long-term prognosis of severe&#xD;
        tuberculosis patients. All cases of severe tuberculosis diagnosed between 2016 and 2021 were&#xD;
        included in the electronic medical record system of one center, and data such as&#xD;
        demographics, hospitalization information, clinical information, laboratory or imaging&#xD;
        examinations, treatment plans, and outcomes were collected.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 13, 2018</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>2-year survival rate</measure>
      <time_frame>2 years</time_frame>
      <description>2-year survival rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>2-year disability rate</measure>
      <time_frame>2 years</time_frame>
      <description>2-year disability rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of participants with the presence of clinical symptoms</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of complications in patients with different treatment regimens</measure>
      <time_frame>2 years</time_frame>
      <description>Incidence of complications in patients with different treatment regimens</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay for patients</measure>
      <time_frame>2 years</time_frame>
      <description>Length of hospital stay for patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients admitted to the ICU</measure>
      <time_frame>2 years</time_frame>
      <description>Proportion of patients admitted to the ICU</description>
    </secondary_outcome>
    <enrollment type="Anticipated">900</enrollment>
    <condition>Tuberculosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Hospitalized patients diagnosed with severe tuberculosis from the Grade A tertiary hospital&#xD;
          in Hubei Province, China.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. For patients with severe pulmonary tuberculosis, imaging and grading diagnosis meet&#xD;
               any of the following:&#xD;
  &#xD;
                 1. Damaged lung ≥ 1 lobe&#xD;
  &#xD;
                 2. Chest CT shows lesions in ≥3 lung lobes&#xD;
  &#xD;
                 3. Hematogenous disseminated pulmonary tuberculosis&#xD;
  &#xD;
                 4. caseous pneumonia&#xD;
  &#xD;
                 5. bronchial tuberculosis&#xD;
  &#xD;
                 6. Multiple hilar or mediastinal lymph node enlargement in primary pulmonary&#xD;
                    tuberculosis&#xD;
  &#xD;
                 7. Rifampicin-resistant, multidrug-resistant, polydrug-resistant or&#xD;
                    pan-drug-resistant tuberculosis&#xD;
  &#xD;
                 8. Combined more than 2 cavities over 8mm&#xD;
  &#xD;
                 9. Tuberculous massive hemoptysis&#xD;
  &#xD;
                10. Pulmonary tuberculosis complicated with acute infection (including&#xD;
                    multidrug-resistant bacterial infection, fungal infection or multiple infection)&#xD;
  &#xD;
                11. Combined with extrapulmonary tuberculosis&#xD;
  &#xD;
                      -  Intracranial tuberculosis, spinal cord and/or meningeal tuberculosis&#xD;
  &#xD;
                      -  Pleural effusion, pericardial effusion&#xD;
  &#xD;
                           -  Empyema or empyema, hemopneumothorax, tracheobronchopleural fistula and&#xD;
                              severe infection.&#xD;
  &#xD;
                           -  Heart failure caused by cardiac tamponade or constrictive pericarditis&#xD;
  &#xD;
                      -  Multiple sites of lymphatic tuberculosis or surgery is necessary&#xD;
  &#xD;
                           -  Cervical lymphatic tuberculosis&#xD;
  &#xD;
                           -  Mediastinal lymphatic tuberculosis&#xD;
  &#xD;
                           -  Abdominal or retroperitoneal lymph node tuberculosis&#xD;
  &#xD;
                      -  Abdominal tuberculosis, tuberculous peritonitis (ascites or multiple serous&#xD;
                         cavities)&#xD;
  &#xD;
                           -  Intestinal tuberculosis causes complete or incomplete intestinal root&#xD;
                              obstruction or perforation or massive bleeding or severe abdominal&#xD;
                              infection&#xD;
  &#xD;
                           -  Gastrointestinal hemorrhage caused by tuberculosis of the digestive&#xD;
                              system, etc.&#xD;
  &#xD;
                      -  Musculoskeletal tuberculosis&#xD;
  &#xD;
                           -  Spinal (cervical, thoracic, lumbar, sacral) tuberculosis&#xD;
  &#xD;
                           -  Bones in other parts&#xD;
  &#xD;
                           -  Merge surrounding abscess&#xD;
  &#xD;
                      -  Urinary or renal tuberculosis&#xD;
  &#xD;
                           -  Renal failure or damaged blood vessels caused by renal tuberculosis&#xD;
  &#xD;
                           -  Ureteral stenosis or blockage caused by urinary tuberculosis&#xD;
  &#xD;
                      -  Adrenal tuberculosis in hypoadrenal insufficiency&#xD;
  &#xD;
                      -  Liver tuberculosis&#xD;
  &#xD;
            2. Age and gender are not limited.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with no clear diagnosis at discharge.&#xD;
  &#xD;
            -  Patients judged by the investigator to be unsuitable for inclusion in this protocol.&#xD;
  &#xD;
            -  The discharge diagnosis was central nervous system tuberculosis, or tuberculous&#xD;
               meningitis, or tuberculous cerebrospinal meningitis, or tuberculous&#xD;
               meningoencephalitis, or tuberculous encephalitis, or tuberculous brain abscess, or&#xD;
               spinal tuberculosis, or tuberculous Hydrocephalus, and is currently participating in&#xD;
               other clinical studies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Wuhan Pulmonary Hospital(Wuhan Institute for Tuberculosis Control)</name>
        <address>
          <city>Hubei</city>
          <state>Wuhan</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Qin Ning</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tuberculosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021041
  org study id: RETUBO-S
  nct id: NCT06021041
  lead sponsor: 
  This is a retrospective clinical study to analyze the clinical characteristics,
        complications, and effects of different treatment options on long-term prognosis of severe
        tuberculosis patients. All cases of severe tuberculosis diagnosed between 2016 and 2021 were
        included in the electronic medical record system of one center, and data such as
        demographics, hospitalization information, clinical information, laboratory or imaging
        examinations, treatment plans, and outcomes were collected.
  observational model: Cohort
  time perspective: Retrospective
  measure: 2-year survival rate
  time frame: 2 years
  description: 2-year survival rate
  measure: 2-year disability rate
  time frame: 2 years
  description: 2-year disability rate
  measure: The number of participants with the presence of clinical symptoms
  time frame: 2 years
  measure: Incidence of complications in patients with different treatment regimens
  time frame: 2 years
  description: Incidence of complications in patients with different treatment regimens
  measure: Length of hospital stay for patients
  time frame: 2 years
  description: Length of hospital stay for patients
  measure: Proportion of patients admitted to the ICU
  time frame: 2 years
  description: Proportion of patients admitted to the ICU
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Qin Ning
  investigator title: Professor
  mesh term: Tuberculosis