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/NCT06007326</url>
    </required_header>
    <id_info>
      <org_study_id>REBEL</org_study_id>
      <nct_id>NCT06007326</nct_id>
    </id_info>
    <brief_title>A Multicentre, Retrospective Study of Clinical Characteristics and Long-term Outcomes of Patients With Brucellosis</brief_title>
    <official_title>A Multicentre, Retrospective Study of Clinical Characteristics and Long-term Outcomes of Patients With Brucellosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qin Ning</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <brief_summary>
      <textblock>
        This is a multicenter, retrospective clinical study, in patients with brucellosis, to analyze&#xD;
        the clinical characteristics, complications, and the impact of different treatment options on&#xD;
        long-term prognosis of patients with brucellosis. All hospitalized patients diagnosed with&#xD;
        brucellosis between 2016 and 2021 were included from the electronic medical record systems of&#xD;
        eight centers, collecting demographics, hospitalization information, clinical information,&#xD;
        laboratories, imaging studies, treatment regimens, and disease outcome and other information.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 27, 2022</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical characteristics</measure>
      <time_frame>2 year</time_frame>
      <description>The electronic medical record system was used to collect patients' symptoms from baseline (admission) to 24 months, including initial symptoms, constitutional symptoms and signs [fever (maximum temperature, duration), hyperhidrosis, muscle/joint soreness, fatigue, hepatomegaly, splenomegaly, testicular enlargement, oophoritis, lymphadenopathy (location and size), others].</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Complication rate</measure>
      <time_frame>2 year</time_frame>
      <description>Electronic medical record system was used to collect the complications of patients from baseline (admission) to 24 months, and the incidence of complications within 2 years was calculated.&#xD;
  Complications include osteoarticular system (sacroiliitis, spondylitis, peripheral arthritis, osteomyelitis, bone destruction, etc.) that may be related to brucellosis, Genitourinary system (orchitis, epididymitis, oophoritis, glomerulonephritis, renal abscess, etc.), central nervous system (peripheral neuropathy, meningoencephalitis, mental symptoms, cranial nerves, chorea, etc.), skin (maculopapular rash, Cyst, Stevens-Johnson syndrome, etc.), respiratory system (pleural effusion, pneumonia, etc.), blood system (leukocyte increase or decrease, platelet deficiency, etc.), cardiovascular system (endocarditis, vasculitis, myocarditis wait). Diagnostic tests for complications include laboratory tests (blood routine, etc.), echocardiography, imaging tests (X-ray, ultrasound, high-resolution CT)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Survival rate</measure>
      <time_frame>1 year,2 years</time_frame>
      <description>The 1-year survival rate and 2-year survival rate were calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease outcome (cured, improved, not cured, progress, relapse, death)</measure>
      <time_frame>2 year</time_frame>
      <description>The electronic medical record system was used to collect the disease outcomes of patients from baseline (admission) to 24 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Etiological characteristics (B.melitensis [1, 2, 3 subtypes], B.abortus[1-9 subtypes], B.suis [1-5 subtypes], B.canis)</measure>
      <time_frame>2 year</time_frame>
      <description>Etiologic characteristics were collected from baseline (admission) through 24 months with the use of an electronic medical record system. The distribution of pathogens was analyzed, and the relationship between different pathogenic characteristics and long-term prognosis (disease outcome) was evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with severe brucellosis (ICU number)</measure>
      <time_frame>2 year</time_frame>
      <description>The electronic medical record system was used to collect the proportion of patients admitted to ICU from baseline (admission) to 24 months, and the proportion of patients admitted to ICU was calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>antimicrobial therapy</measure>
      <time_frame>2 year</time_frame>
      <description>The electronic medical record system was used to collect the treatment options of patients from baseline (admission) to 24 months, and the impact of different treatment options on prognosis (disease outcome) was evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital costs</measure>
      <time_frame>2 year</time_frame>
      <description>The electronic medical record system was used to collect the hospitalization expenses of patients, and the average hospitalization cost was calculated.</description>
    </secondary_outcome>
    <enrollment type="Actual">200</enrollment>
    <condition>Brucellosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Hospitalized patients diagnosed with Brucellosis from 8 centers in Hubei Province, China.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age and gender are not limited;&#xD;
  &#xD;
            -  Discharged patients diagnosed with brucellosis&#xD;
  &#xD;
            -  Specific reference to the People's Republic of China's health industry standard&#xD;
               &quot;Diagnosis for brucellosis&quot; (WS269-2019) diagnosed as a patient with brucellosis, that&#xD;
               is, the patient meets a suspected or clinically diagnosed case and passes the&#xD;
               confirmatory test mentioned below at the same time Either to prove:&#xD;
  &#xD;
                 1. Brucella is isolated from any pathological material culture such as blood, bone&#xD;
                    marrow, other body fluids and excreta of patients.&#xD;
  &#xD;
                 2. The test tube agglutination test (SAT) titer is 1:100++ and above, or the&#xD;
                    patient's course of disease lasts for more than one year and still has clinical&#xD;
                    symptoms, and the titer is 1:50++ and above.&#xD;
  &#xD;
                 3. Complement fixation test (CFT) titer is 1:10++ and above.&#xD;
  &#xD;
                 4. Anti-human immunoglobulin test (Coomb's) titer is 1:400++ and above.&#xD;
  &#xD;
            -  Volunteer to join this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of severe lumbar spine trauma before the diagnosis of brucellosis;&#xD;
  &#xD;
            -  Have undergone lumbosacral surgery before the diagnosis of brucellosis;&#xD;
  &#xD;
            -  Scoliosis;&#xD;
  &#xD;
            -  Currently participating in clinical trials of other drugs or medical devices;&#xD;
  &#xD;
            -  The researchers think it is not suitable for inclusion.&#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>People's Hospital of Luotian County</name>
        <address>
          <city>Huanggang</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Qianjiang Central Hospital</name>
        <address>
          <city>Qianjiang</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Xianning Central Hospital</name>
        <address>
          <city>Xianning</city>
          <state>Hu Bei Province</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Guangshui First Peoples Hospital</name>
        <address>
          <city>Guangshui</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Huanggang Central Hospital</name>
        <address>
          <city>Huanggang</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology</name>
        <address>
          <city>Macheng</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <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>Yichang Third Peoples Hospital</name>
        <address>
          <city>Yichang</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-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>Brucellosis</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/NCT06007326
  org study id: REBEL
  nct id: NCT06007326
  lead sponsor: 
  This is a multicenter, retrospective clinical study, in patients with brucellosis, to analyze
        the clinical characteristics, complications, and the impact of different treatment options on
        long-term prognosis of patients with brucellosis. All hospitalized patients diagnosed with
        brucellosis between 2016 and 2021 were included from the electronic medical record systems of
        eight centers, collecting demographics, hospitalization information, clinical information,
        laboratories, imaging studies, treatment regimens, and disease outcome and other information.
  observational model: Cohort
  time perspective: Retrospective
  measure: Clinical characteristics
  time frame: 2 year
  description: The electronic medical record system was used to collect patients' symptoms from baseline (admission) to 24 months, including initial symptoms, constitutional symptoms and signs [fever (maximum temperature, duration), hyperhidrosis, muscle/joint soreness, fatigue, hepatomegaly, splenomegaly, testicular enlargement, oophoritis, lymphadenopathy (location and size), others].
  measure: Complication rate
  time frame: 2 year
  description: Electronic medical record system was used to collect the complications of patients from baseline (admission) to 24 months, and the incidence of complications within 2 years was calculated.
  Complications include osteoarticular system (sacroiliitis, spondylitis, peripheral arthritis, osteomyelitis, bone destruction, etc.) that may be related to brucellosis, Genitourinary system (orchitis, epididymitis, oophoritis, glomerulonephritis, renal abscess, etc.), central nervous system (peripheral neuropathy, meningoencephalitis, mental symptoms, cranial nerves, chorea, etc.), skin (maculopapular rash, Cyst, Stevens-Johnson syndrome, etc.), respiratory system (pleural effusion, pneumonia, etc.), blood system (leukocyte increase or decrease, platelet deficiency, etc.), cardiovascular system (endocarditis, vasculitis, myocarditis wait). Diagnostic tests for complications include laboratory tests (blood routine, etc.), echocardiography, imaging tests (X-ray, ultrasound, high-resolution CT)
  measure: Survival rate
  time frame: 1 year,2 years
  description: The 1-year survival rate and 2-year survival rate were calculated.
  measure: Disease outcome (cured, improved, not cured, progress, relapse, death)
  time frame: 2 year
  description: The electronic medical record system was used to collect the disease outcomes of patients from baseline (admission) to 24 months.
  measure: Etiological characteristics (B.melitensis [1, 2, 3 subtypes], B.abortus[1-9 subtypes], B.suis [1-5 subtypes], B.canis)
  time frame: 2 year
  description: Etiologic characteristics were collected from baseline (admission) through 24 months with the use of an electronic medical record system. The distribution of pathogens was analyzed, and the relationship between different pathogenic characteristics and long-term prognosis (disease outcome) was evaluated.
  measure: Number of patients with severe brucellosis (ICU number)
  time frame: 2 year
  description: The electronic medical record system was used to collect the proportion of patients admitted to ICU from baseline (admission) to 24 months, and the proportion of patients admitted to ICU was calculated.
  measure: antimicrobial therapy
  time frame: 2 year
  description: The electronic medical record system was used to collect the treatment options of patients from baseline (admission) to 24 months, and the impact of different treatment options on prognosis (disease outcome) was evaluated.
  measure: Hospital costs
  time frame: 2 year
  description: The electronic medical record system was used to collect the hospitalization expenses of patients, and the average hospitalization cost was calculated.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Qin Ning
  investigator title: Professor
  mesh term: Brucellosis