<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/NCT01667991</url>
  </required_header>
  <id_info>
    <org_study_id>MDR in China 123</org_study_id>
    <nct_id>NCT01667991</nct_id>
  </id_info>
  <brief_title>Evaluation of the American Thoracic Society Criteria for Predicting Multidrug-resistant Bacteria in Critically Ill Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve&#xD;
      the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are&#xD;
      different between countries, will affect the accuracy of etiological diagnoses according to&#xD;
      the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the&#xD;
      accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria&#xD;
      in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All data concerning patient characteristics at ICU admission and during ICU stay were&#xD;
      prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates&#xD;
      from intubated patients and specimens from the infection location) was performed at ICU&#xD;
      admission and discharge. Risk factors for infection or colonization with MDR bacteria were&#xD;
      recorded, and the accuracy of the ATS criteria in predicting infection or colonization with&#xD;
      these bacteria at ICU admission was documented. All of the infected patients were treated by&#xD;
      the attending physician, and the choice and adjustment of antibiotic were in accordance with&#xD;
      the recommendations of the ATS guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">610</enrollment>
  <condition>Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients admitted to icu&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients hospitalized in the ICU were eligible for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianfeng Xie, MD</last_name>
    <role>Study Director</role>
    <affiliation>Zhongda Hospital</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 17, 2012</last_update_submitted>
  <last_update_submitted_qc>August 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jianfeng Xie</investigator_full_name>
    <investigator_title>Department of Critical Care Medicine, Zhong-Da Hospital, School of Medicine Southeast University</investigator_title>
  </responsible_party>
  <keyword>Colonization</keyword>
  <keyword>infection</keyword>
  <keyword>multidrug-resistant bacteria</keyword>
  <keyword>guideline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</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/NCT01667991
org study id: MDR in China 123
nct id: NCT01667991
lead sponsor: 
has dmc: Yes
Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve
      the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are
      different between countries, will affect the accuracy of etiological diagnoses according to
      the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the
      accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria
      in China.
All data concerning patient characteristics at ICU admission and during ICU stay were
      prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates
      from intubated patients and specimens from the infection location) was performed at ICU
      admission and discharge. Risk factors for infection or colonization with MDR bacteria were
      recorded, and the accuracy of the ATS criteria in predicting infection or colonization with
      these bacteria at ICU admission was documented. All of the infected patients were treated by
      the attending physician, and the choice and adjustment of antibiotic were in accordance with
      the recommendations of the ATS guidelines.
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jianfeng Xie, MD
role: Study Director
affiliation: Zhongda Hospital
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jianfeng Xie
investigator title: Department of Critical Care Medicine, Zhong-Da Hospital, School of Medicine Southeast University
mesh term: Infections