xml: <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/NCT05976581</url>
    </required_header>
    <id_info>
      <org_study_id>2023p00103497</org_study_id>
      <secondary_id>HP-00096125</secondary_id>
      <nct_id>NCT05976581</nct_id>
    </id_info>
    <brief_title>Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients</brief_title>
    <acronym>UP-CAPTAIn</acronym>
    <official_title>Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jonathan Baghdadi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centers for Disease Control and Prevention</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Maryland, Baltimore</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>
        The goal of this prospective randomized study is to improve antibiotic use among hospitalized&#xD;
        patients with suspected pneumonia. An alert was built into the electronic health record to&#xD;
        guide use of diagnostic testing based on probability of bacterial pneumonia. Patients with&#xD;
        test results suggesting viral infection will be randomized to either: (1) receive a&#xD;
        structured communication from the antimicrobial stewardship team to de-escalate antibiotics&#xD;
        or (2) usual care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic&#xD;
        therapy. In this study, an alert will appear in the electronic health record of patients&#xD;
        undergoing molecular diagnostic testing for respiratory symptoms that provides options for&#xD;
        diagnostic testing based on pre-test probability of bacterial infection. Patients with test&#xD;
        results suggesting possible viral infection will be randomized to either usual care or to&#xD;
        receive test results along with structured guidance from antimicrobial stewardship to&#xD;
        consider discontinuing or de-escalating antibiotics. This guidance, which will include an&#xD;
        explicit calculation of the post-test probability of bacterial infection based on considering&#xD;
        risk factors, vital signs, symptoms, and available imaging, will be communicated to the&#xD;
        primary care team via direct electronic message and a summary note in the patient's chart.&#xD;
        The final decision on whether to continue antibiotic therapy will be up to the primary team.&#xD;
        The primary outcome of interest will be in-hospital antibiotic use. Safety outcomes will&#xD;
        include length of stay, readmissions, hospital-free days, and mortality.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hospital antibiotic days of therapy</measure>
      <time_frame>Up to 90 days after randomization</time_frame>
      <description>The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter, from arrival in the emergency department or on the hospital ward until discharge.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hospital length of stay</measure>
      <time_frame>Up to 90 days after randomization</time_frame>
      <description>Duration of hospitalization from admission to discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In-hospital mortality</measure>
      <time_frame>Up to 90 days after randomization</time_frame>
      <description>Death or discharge to hospice during initial hospitalization for any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmissions within 30-days of randomization</measure>
      <time_frame>Within 30 days after randomization</time_frame>
      <description>Readmissions for any cause within 30-days of randomization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>C. difficile infections in the 30-days post-randomization</measure>
      <time_frame>Within 30 days after randomization</time_frame>
      <description>Positive test for C. difficile associated with initiation of antibiotics targeting C. difficile.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute kidney injury</measure>
      <time_frame>Within 14 days of randomization</time_frame>
      <description>Defined by an elevation in creatinine of &gt; 0.5mg/dl or 2x baseline in a patient without previous end-stage renal disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilator-free days in the 30-days post-randomization</measure>
      <time_frame>30 days after randomization.</time_frame>
      <description>Days without a requirement for mechanical ventilation in the 30 days after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital-free days in the 30-days post-randomization</measure>
      <time_frame>30 days after randomization.</time_frame>
      <description>Days without hospitalization in the 30 days after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antibiotic de-escalations within 72 hours after initiation</measure>
      <time_frame>3 days after randomization.</time_frame>
      <description>Including narrowing, discontinuing, or converting the route of administration from intravenous to oral.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Pneumonia</condition>
    <condition>Pneumonia, Viral</condition>
    <condition>Pneumonia, Bacterial</condition>
    <arm_group>
      <arm_group_label>Electronic alert plus structured communication of test results</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Electronic alert without structured communication of test results</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>An electronic health record alert will guide diagnostic testing for pneumonia. The primary care team will access and interpret test results and decide upon composition and duration of antimicrobial without external guidance.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Electronic alert</intervention_name>
      <description>An alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia.</description>
      <arm_group_label>Electronic alert plus structured communication of test results</arm_group_label>
      <arm_group_label>Electronic alert without structured communication of test results</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Structured communication of test results</intervention_name>
      <description>A clinical research team member will send an electronic message to the primary care team on behalf of the antimicrobial stewardship program with structured guidance to stop or de-escalate antibiotics and document these recommendations in the patient's chart.</description>
      <arm_group_label>Electronic alert plus structured communication of test results</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients admitted to the University of Maryland Medical Center or University of&#xD;
               Maryland Medical Center-Midtown Campus who are prescribed antibiotics for suspected&#xD;
               community-acquired respiratory infection.&#xD;
  &#xD;
            -  Protocol-based diagnostic testing supports possible viral infection, either by&#xD;
               positive molecular test or low procalcitonin value.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hospitalization for &gt;72 hours prior to protocol-based diagnostic testing.&#xD;
  &#xD;
            -  Previous molecular testing for viral infection during the same hospital encounter.&#xD;
  &#xD;
            -  Severely immunosuppressed, defined as having hematologic malignancy, solid organ tumor&#xD;
               on chemotherapy, or solid organ transplant on immunosuppression&#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>Daniel J. Morgan, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Maryland, Baltimore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jonathan D Baghdadi, MD, PhD</last_name>
      <phone>410-706-0134</phone>
      <email>jbaghdadi@som.umaryland.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
      <investigator_full_name>Jonathan Baghdadi</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>diagnostic stewardship</keyword>
    <keyword>antimicrobial stewardship</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumonia</mesh_term>
      <mesh_term>Pneumonia, Viral</mesh_term>
      <mesh_term>Pneumonia, Bacterial</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976581
  org study id: 2023p00103497
  secondary id: HP-00096125
  nct id: NCT05976581
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective randomized study is to improve antibiotic use among hospitalized
        patients with suspected pneumonia. An alert was built into the electronic health record to
        guide use of diagnostic testing based on probability of bacterial pneumonia. Patients with
        test results suggesting viral infection will be randomized to either: (1) receive a
        structured communication from the antimicrobial stewardship team to de-escalate antibiotics
        or (2) usual care.
  Low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic
        therapy. In this study, an alert will appear in the electronic health record of patients
        undergoing molecular diagnostic testing for respiratory symptoms that provides options for
        diagnostic testing based on pre-test probability of bacterial infection. Patients with test
        results suggesting possible viral infection will be randomized to either usual care or to
        receive test results along with structured guidance from antimicrobial stewardship to
        consider discontinuing or de-escalating antibiotics. This guidance, which will include an
        explicit calculation of the post-test probability of bacterial infection based on considering
        risk factors, vital signs, symptoms, and available imaging, will be communicated to the
        primary care team via direct electronic message and a summary note in the patient's chart.
        The final decision on whether to continue antibiotic therapy will be up to the primary team.
        The primary outcome of interest will be in-hospital antibiotic use. Safety outcomes will
        include length of stay, readmissions, hospital-free days, and mortality.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Hospital antibiotic days of therapy
  time frame: Up to 90 days after randomization
  description: The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter, from arrival in the emergency department or on the hospital ward until discharge.
  measure: Hospital length of stay
  time frame: Up to 90 days after randomization
  description: Duration of hospitalization from admission to discharge
  measure: In-hospital mortality
  time frame: Up to 90 days after randomization
  description: Death or discharge to hospice during initial hospitalization for any cause
  measure: Readmissions within 30-days of randomization
  time frame: Within 30 days after randomization
  description: Readmissions for any cause within 30-days of randomization
  measure: C. difficile infections in the 30-days post-randomization
  time frame: Within 30 days after randomization
  description: Positive test for C. difficile associated with initiation of antibiotics targeting C. difficile.
  measure: Acute kidney injury
  time frame: Within 14 days of randomization
  description: Defined by an elevation in creatinine of > 0.5mg/dl or 2x baseline in a patient without previous end-stage renal disease.
  measure: Ventilator-free days in the 30-days post-randomization
  time frame: 30 days after randomization.
  description: Days without a requirement for mechanical ventilation in the 30 days after randomization.
  measure: Hospital-free days in the 30-days post-randomization
  time frame: 30 days after randomization.
  description: Days without hospitalization in the 30 days after randomization.
  measure: Antibiotic de-escalations within 72 hours after initiation
  time frame: 3 days after randomization.
  description: Including narrowing, discontinuing, or converting the route of administration from intravenous to oral.
  arm group label: Electronic alert plus structured communication of test results
  arm group type: Experimental
  description: An electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics.
  arm group label: Electronic alert without structured communication of test results
  arm group type: Active Comparator
  description: An electronic health record alert will guide diagnostic testing for pneumonia. The primary care team will access and interpret test results and decide upon composition and duration of antimicrobial without external guidance.
  intervention type: Behavioral
  intervention name: Electronic alert
  description: An alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia.
  arm group label: Electronic alert plus structured communication of test results
  arm group label: Electronic alert without structured communication of test results
  intervention type: Behavioral
  intervention name: Structured communication of test results
  description: A clinical research team member will send an electronic message to the primary care team on behalf of the antimicrobial stewardship program with structured guidance to stop or de-escalate antibiotics and document these recommendations in the patient's chart.
  arm group label: Electronic alert plus structured communication of test results
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel J. Morgan, MD, MS
  role: Principal Investigator
  affiliation: University of Maryland, Baltimore
  last name: Jonathan D Baghdadi, MD, PhD
  phone: 410-706-0134
  email: jbaghdadi@som.umaryland.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Maryland, Baltimore
  investigator full name: Jonathan Baghdadi
  investigator title: Assistant Professor
  mesh term: Pneumonia
  mesh term: Pneumonia, Viral
  mesh term: Pneumonia, Bacterial
  sharing ipd: No