<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/NCT03765749</url>
  </required_header>
  <id_info>
    <org_study_id>PMK-032</org_study_id>
    <nct_id>NCT03765749</nct_id>
  </id_info>
  <brief_title>Empirical Antibiotic and Outcome in Community-onset Bacteremia</brief_title>
  <official_title>Empirical Antibiotic and Outcome in Community-onset Bacteremia Caused by Third Generation Cephalosporin Resistant Enterobacteriaceae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Phramongkutklao College of Medicine and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Phramongkutklao College of Medicine and Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Empirical antibiotic and outcome in Community-onset Bacteremia Caused by third generation&#xD;
      cephalosporin resistant Enterobacteriaceae&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective cohort study is conducted for monitoring outcomes and risk factors among&#xD;
      community-onset bacteremia caused by third generation cephalosporin resistant&#xD;
      enterobacteriaceae.&#xD;
&#xD;
      Primary endpoint is mortality rate among those who received initially inappropriate&#xD;
      antimicrobial which switch to appropriate antimicrobial later when culture and antimicrobial&#xD;
      susceptibility test reported among community-onset bacteremia caused by third generation&#xD;
      cephalosporin resistant enterobacteriaceae.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae</measure>
    <time_frame>January 2018 - march 2019</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">108</enrollment>
  <condition>Bacteremia</condition>
  <arm_group>
    <arm_group_label>Community onset 3rd generation cephalosporin resistant entero</arm_group_label>
    <description>Patient with Community onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received inappropriate Antibiotic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nosocomial onset 3rd generation cephalosporin resistant ente</arm_group_label>
    <description>Patient with Nosocomial onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received appropriate Antibiotic</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with community-onset bacteremia caused by third generation cephalosporin resistant&#xD;
        enterobacteriaceae. Age &gt; 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with Community-onset Bacteremia Caused by third generation cephalosporin&#xD;
             resistant Enterobacteriaceae. Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Polymicrobial infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Worapong Nasomsong</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>March 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Phramongkutklao College of Medicine and Hospital</investigator_affiliation>
    <investigator_full_name>Vasin Vasikasin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteremia</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/NCT03765749
org study id: PMK-032
nct id: NCT03765749
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Empirical antibiotic and outcome in Community-onset Bacteremia Caused by third generation
      cephalosporin resistant Enterobacteriaceae
Prospective cohort study is conducted for monitoring outcomes and risk factors among
      community-onset bacteremia caused by third generation cephalosporin resistant
      enterobacteriaceae.

      Primary endpoint is mortality rate among those who received initially inappropriate
      antimicrobial which switch to appropriate antimicrobial later when culture and antimicrobial
      susceptibility test reported among community-onset bacteremia caused by third generation
      cephalosporin resistant enterobacteriaceae.
observational model: Cohort
time perspective: Prospective
measure: Mortality rate among community-onset bacteremia caused by third generation cephalosporin resistant enterobacteriaceae
time frame: January 2018 - march 2019
arm group label: Community onset 3rd generation cephalosporin resistant entero
description: Patient with Community onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received inappropriate Antibiotic
arm group label: Nosocomial onset 3rd generation cephalosporin resistant ente
description: Patient with Nosocomial onset third generation cephalosporin resistant enterobacteriaceae bacteremia who received appropriate Antibiotic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Phramongkutklao College of Medicine and Hospital
investigator full name: Vasin Vasikasin
investigator title: Principal Investigator
mesh term: Bacteremia
sharing ipd: No