<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/NCT04404582</url>
  </required_header>
  <id_info>
    <org_study_id>K2019-06-031</org_study_id>
    <nct_id>NCT04404582</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics for the Critical Ill Patients With Klebsiella Pneumoniae Infection</brief_title>
  <official_title>Analysis of the Clinical Characteristics for the Critical Ill Patients With Klebsiella Pneumoniae Infection: A Multi-center Research in the Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Provincial 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>
      The detection of Klebsiella pneumoniae virulence gene and antibiotics resistance gene takes a&#xD;
      long time and high cost with equipment requirements. Distinguishing the Klebsiella pneumoniae&#xD;
      by gene were late for clinical treatment. Therefore, the investigators aim to study the&#xD;
      clinical characteristics of critically ill patients with Klebsiella pneumoniae infection&#xD;
      which expressed different drug sensitivity test results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical data of adult patients in integrated ICUs of 6 hospitals of Fujian Province China&#xD;
      from January 2015 to July 2019 were collected, who had been examined for sputum, urine,&#xD;
      blood, pleural effusion, ascites, cerebrospinal fluid and wound secretions and other body&#xD;
      fluid samples. And the results showed that Klebsiella pneumoniae was positive, including&#xD;
      demographic data, underlying disease status, drug sensitivity test, infection-related&#xD;
      indicators, life support, prognostic indicators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prognostic indicators</measure>
    <time_frame>30 day</time_frame>
    <description>30-day survival rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICU stays</measure>
    <time_frame>about a mouth</time_frame>
    <description>the length that patients stay in ICU</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">546</enrollment>
  <condition>Drug Resistance</condition>
  <arm_group>
    <arm_group_label>Klebsiella pneumoniae</arm_group_label>
    <description>patients with Klebsiella pneumoniae infection had different results of the drug sensitivity test. we compared the prognosis of these patients.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult whose body fluid were sampled during ICU stay and Klebsiella pneumoniae was detected,&#xD;
        followed by drug sensitivity test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult whose body fluid were sampled during ICU stay and Klebsiella pneumoniae was&#xD;
             detected, followed by drug sensitivity test (including reporting the test results&#xD;
             after the patient was transferred out of ICU or died).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age were less than 18 years old;&#xD;
&#xD;
          -  Patients stayed in ICU was less than 48 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
    <investigator_full_name>Xiuling Shang</investigator_full_name>
    <investigator_title>associate senior doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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/NCT04404582
org study id: K2019-06-031
nct id: NCT04404582
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The detection of Klebsiella pneumoniae virulence gene and antibiotics resistance gene takes a
      long time and high cost with equipment requirements. Distinguishing the Klebsiella pneumoniae
      by gene were late for clinical treatment. Therefore, the investigators aim to study the
      clinical characteristics of critically ill patients with Klebsiella pneumoniae infection
      which expressed different drug sensitivity test results.
Clinical data of adult patients in integrated ICUs of 6 hospitals of Fujian Province China
      from January 2015 to July 2019 were collected, who had been examined for sputum, urine,
      blood, pleural effusion, ascites, cerebrospinal fluid and wound secretions and other body
      fluid samples. And the results showed that Klebsiella pneumoniae was positive, including
      demographic data, underlying disease status, drug sensitivity test, infection-related
      indicators, life support, prognostic indicators.
observational model: Other
time perspective: Retrospective
measure: prognostic indicators
time frame: 30 day
description: 30-day survival rate
measure: ICU stays
time frame: about a mouth
description: the length that patients stay in ICU
arm group label: Klebsiella pneumoniae
description: patients with Klebsiella pneumoniae infection had different results of the drug sensitivity test. we compared the prognosis of these patients.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Fujian Provincial Hospital
investigator full name: Xiuling Shang
investigator title: associate senior doctor
mesh term: Pneumonia
sharing ipd: No