<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/NCT03766932</url>
  </required_header>
  <id_info>
    <org_study_id>Rapid diagnosis</org_study_id>
    <nct_id>NCT03766932</nct_id>
  </id_info>
  <brief_title>Antigenic and Antibody Detection of Candida</brief_title>
  <official_title>Department of Pulmonary &amp; Critical Care Medicine, Chinese PLA General Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this study, a multicenter, prospective, synchronous blind, and controlled study was&#xD;
      adopted to set the cut-off values of candida specific IgG, IgM, and Mn with the blood culture&#xD;
      results as the gold standard, so as to evaluate the diagnostic value of candida specific IgG,&#xD;
      IgM, and Mn levels in candida infection.&#xD;
&#xD;
        1. the cut-off values of serum specific IgG, IgM and Mn of candida sinensis infected&#xD;
           population in China were established by comparing the positive results of blood culture&#xD;
           of 300 healthy people and 100 patients with positive candida sinensis blood culture as&#xD;
           the gold standard and using ROC curve (ROC curve).&#xD;
&#xD;
        2. 100 patients with positive tracheal aspiration culture and 100 patients with positive&#xD;
           urine culture were enrolled. Serum levels of candida specific IgG, IgM and Mn were&#xD;
           detected, and sensitivity, specificity, positive predictive value, negative predictive&#xD;
           value and likelihood ratio of candida specific IgG, IgM and Mn in tracheal aspiration&#xD;
           and urine were evaluated.&#xD;
&#xD;
        3. 200 high risk patients with candida infection were enrolled, and the aseptic fluid&#xD;
           culture and the simultaneous detection of serum specific IgG, IgM and Mn were adopted to&#xD;
           explore the diagnostic value of the detection method.&#xD;
&#xD;
        4. positive candida culture in sputum and positive candida culture in tracheal aspirate&#xD;
           were taken as the control group to compare the levels of IgG, IgM and Mn in serum of the&#xD;
           two groups, and to explore the diagnostic value of different sampling methods for&#xD;
           candida pulmonary infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>1 Month</target_duration>
  <primary_outcome>
    <measure>Serum specific IgG, IgM and Mn levels in the enrolled population</measure>
    <time_frame>1-2 years</time_frame>
    <description>ELISA was used to detect the samples</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection</condition>
  <arm_group>
    <arm_group_label>Blood culture candida positive group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Tracheal aspiration candida culture positive group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Urine candida culture positive group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Other aseptic humoral candida positive group</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with positive aseptic humoral culture among hospitalized patients.The control&#xD;
        group were volunteers for outpatient or physical examination&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Age: (1) 18-85 years old; (2) Candida positive in aseptic humoral&#xD;
        culture&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:(1) no informed consent has been signed; (2) patients with severe immune&#xD;
        deficiency -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>kaifei wang, doctor</last_name>
    <phone>15001028681</phone>
    <email>wangkaifei@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lixin xie, doctor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>wang kaifei</investigator_full_name>
    <investigator_title>xie lixin</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</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/NCT03766932
org study id: Rapid diagnosis
nct id: NCT03766932
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, a multicenter, prospective, synchronous blind, and controlled study was
      adopted to set the cut-off values of candida specific IgG, IgM, and Mn with the blood culture
      results as the gold standard, so as to evaluate the diagnostic value of candida specific IgG,
      IgM, and Mn levels in candida infection.

        1. the cut-off values of serum specific IgG, IgM and Mn of candida sinensis infected
           population in China were established by comparing the positive results of blood culture
           of 300 healthy people and 100 patients with positive candida sinensis blood culture as
           the gold standard and using ROC curve (ROC curve).

        2. 100 patients with positive tracheal aspiration culture and 100 patients with positive
           urine culture were enrolled. Serum levels of candida specific IgG, IgM and Mn were
           detected, and sensitivity, specificity, positive predictive value, negative predictive
           value and likelihood ratio of candida specific IgG, IgM and Mn in tracheal aspiration
           and urine were evaluated.

        3. 200 high risk patients with candida infection were enrolled, and the aseptic fluid
           culture and the simultaneous detection of serum specific IgG, IgM and Mn were adopted to
           explore the diagnostic value of the detection method.

        4. positive candida culture in sputum and positive candida culture in tracheal aspirate
           were taken as the control group to compare the levels of IgG, IgM and Mn in serum of the
           two groups, and to explore the diagnostic value of different sampling methods for
           candida pulmonary infection.
observational model: Cohort
time perspective: Prospective
measure: Serum specific IgG, IgM and Mn levels in the enrolled population
time frame: 1-2 years
description: ELISA was used to detect the samples
arm group label: Blood culture candida positive group
arm group label: Tracheal aspiration candida culture positive group
arm group label: Urine candida culture positive group
arm group label: Other aseptic humoral candida positive group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: kaifei wang, doctor
phone: 15001028681
email: wangkaifei@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: wang kaifei
investigator title: xie lixin
mesh term: Candidiasis