<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/NCT04448665</url>
  </required_header>
  <id_info>
    <org_study_id>681006-08</org_study_id>
    <nct_id>NCT04448665</nct_id>
  </id_info>
  <brief_title>Compliance of Initial Empiric Antimicrobial Therapy</brief_title>
  <official_title>The Empiric Antimicrobial Therapy: the Comparison of Initial Clinical Choice of Drugs With the Results of Microbiological Investigations - an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Institute od Medicine National Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Military Institute od Medicine National Research Institute</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>
      Hospital infections comprise about half of all undesirable complications related to hospital&#xD;
      treatment. In case of bacterial infection administration of antimicrobial agent is a therapy&#xD;
      of choice. For maximum effectiveness, antimicrobial agents should be administered quickly in&#xD;
      optimal doses. Moreover, the therapeutic concentration of properly selected drugs should be&#xD;
      achieved as soon as possible. The relation between delays in the administration of&#xD;
      antibiotics and increased mortality is well known. That is why proper empiric therapy is so&#xD;
      important. Before antimicrobial investigation is completed, which may last up to 72 hours, a&#xD;
      wide-spectrum antimicrobial should be administered according to the type of infection, its&#xD;
      origin, and the characteristics of the local pathogens.&#xD;
&#xD;
      The objective of this study is to compare the initial choice of empiric antimicrobial therapy&#xD;
      and the results of both microbiological identification and susceptibility/resistance analysis&#xD;
      of isolated pathogens.&#xD;
&#xD;
      This project was designed as a prospective cohort study. Analysis was performed in a large&#xD;
      multidisciplinary academic hospital and trauma center. All decisions on empiric therapy with&#xD;
      antimicrobial used in infections caused by multidrug-resistant pathogens, that are made in&#xD;
      different hospital wards except intensive care, are required by hospital procedures to be&#xD;
      confirmed by intensivists. In our analysis, the initial choice of empiric therapy in the&#xD;
      hospital wards other than the critical care unit was compared with the results of&#xD;
      microbiological investigations and susceptibility/resistance analyses of isolated pathogens.&#xD;
&#xD;
      Accurate microbial identification was performed with a VITEK® 2 automatic testing system. The&#xD;
      microbroth dilution method with VITEK® 2 AST cards was used for the antibiotic susceptibility&#xD;
      testing of isolated pathogens.&#xD;
&#xD;
      Microbiological analyses were performed between 2018 and 2020 according to the regulations of&#xD;
      the European Committee on Antimicrobial Susceptibility (EUCAST, version 9.0, 2019) and the&#xD;
      National Reference Centre for Susceptibility Testing (NRCST, Warsaw, Poland).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</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>Accuracy of initial empiric therapy</measure>
    <time_frame>Immediately after the completion of microbiological analyses</time_frame>
    <description>The comparison of initially administered antimicrobial agent with the results of microbiological analyses (susceptibility/resistance of the isolated pathogen).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">267</enrollment>
  <condition>Anti-Infective Agents</condition>
  <arm_group>
    <arm_group_label>patients with suspected infection</arm_group_label>
    <description>The hospitalized patients in whom, based on clinical signs and symptoms, an infection is suspected, and an administration of antimicrobial agents as empiric therapy is necessary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>microbiological investigation</intervention_name>
    <description>a microbiological tests, including isolation of the pathogen and analysis of their susceptibility/resistance to antimicrobial agents</description>
    <arm_group_label>patients with suspected infection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Due to study design we performed no descriptive analyses of the study population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Eligibility Criteria:&#xD;
&#xD;
        - all patients in whom, based on clinical signs and symptoms, an infection is suspected,&#xD;
        and an administration of antimicrobial agents as empiric therapy was necessary&#xD;
&#xD;
        Eclusion Criteria:&#xD;
&#xD;
        - none.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dariusz Tomaszewski, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anesthesiology and Intensive Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Therapy</name>
      <address>
        <city>Warsaw</city>
        <zip>04-141</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Military Institute od Medicine National Research Institute</investigator_affiliation>
    <investigator_full_name>Dariusz Tomaszewski</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>empirical therapy</keyword>
  <keyword>antimicrobial agents</keyword>
  <keyword>hospital infections</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04448665
org study id: 681006-08
nct id: NCT04448665
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hospital infections comprise about half of all undesirable complications related to hospital
      treatment. In case of bacterial infection administration of antimicrobial agent is a therapy
      of choice. For maximum effectiveness, antimicrobial agents should be administered quickly in
      optimal doses. Moreover, the therapeutic concentration of properly selected drugs should be
      achieved as soon as possible. The relation between delays in the administration of
      antibiotics and increased mortality is well known. That is why proper empiric therapy is so
      important. Before antimicrobial investigation is completed, which may last up to 72 hours, a
      wide-spectrum antimicrobial should be administered according to the type of infection, its
      origin, and the characteristics of the local pathogens.

      The objective of this study is to compare the initial choice of empiric antimicrobial therapy
      and the results of both microbiological identification and susceptibility/resistance analysis
      of isolated pathogens.

      This project was designed as a prospective cohort study. Analysis was performed in a large
      multidisciplinary academic hospital and trauma center. All decisions on empiric therapy with
      antimicrobial used in infections caused by multidrug-resistant pathogens, that are made in
      different hospital wards except intensive care, are required by hospital procedures to be
      confirmed by intensivists. In our analysis, the initial choice of empiric therapy in the
      hospital wards other than the critical care unit was compared with the results of
      microbiological investigations and susceptibility/resistance analyses of isolated pathogens.

      Accurate microbial identification was performed with a VITEK® 2 automatic testing system. The
      microbroth dilution method with VITEK® 2 AST cards was used for the antibiotic susceptibility
      testing of isolated pathogens.

      Microbiological analyses were performed between 2018 and 2020 according to the regulations of
      the European Committee on Antimicrobial Susceptibility (EUCAST, version 9.0, 2019) and the
      National Reference Centre for Susceptibility Testing (NRCST, Warsaw, Poland).
observational model: Cohort
time perspective: Prospective
measure: Accuracy of initial empiric therapy
time frame: Immediately after the completion of microbiological analyses
description: The comparison of initially administered antimicrobial agent with the results of microbiological analyses (susceptibility/resistance of the isolated pathogen).
arm group label: patients with suspected infection
description: The hospitalized patients in whom, based on clinical signs and symptoms, an infection is suspected, and an administration of antimicrobial agents as empiric therapy is necessary.
intervention type: Diagnostic Test
intervention name: microbiological investigation
description: a microbiological tests, including isolation of the pathogen and analysis of their susceptibility/resistance to antimicrobial agents
arm group label: patients with suspected infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dariusz Tomaszewski, MD, PhD
role: Study Director
affiliation: Department of Anesthesiology and Intensive Therapy
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Military Institute od Medicine National Research Institute
investigator full name: Dariusz Tomaszewski
investigator title: MD, PhD
sharing ipd: Undecided