<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/NCT01662258</url>
  </required_header>
  <id_info>
    <org_study_id>HHSN272201000040C</org_study_id>
    <nct_id>NCT01662258</nct_id>
  </id_info>
  <brief_title>Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP</brief_title>
  <acronym>NIHCAP</acronym>
  <official_title>Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Louisville VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Summa Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ben Taub Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Michael E. DeBakey VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective interventional study to assess laboratory testing which will identify&#xD;
      the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent&#xD;
      selection for patients with community acquired-pneumonia (CAP).&#xD;
&#xD;
      Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with&#xD;
      respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted&#xD;
      narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to&#xD;
      Empiric therapy in patients with viral pneumonia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted at five academic medical university sites with 7 hospitals.&#xD;
      Empiric therapy is defined as selection of antibiotic therapy based on the 2007 ATS-IDSA&#xD;
      guidelines in which broad-spectrum antibiotics are recommended, and microbial cause is&#xD;
      uncertain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Decision by NIH&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration</measure>
    <time_frame>30 days after enrollment</time_frame>
    <description>Symptoms of sputum, cough, shortness of breath. Objective signs of deterioration: Acute Respiratory Distress Syndrome, empyema,nonpulmonary infection by infecting microbe, ICU admission, rehospitalization within 7 days following discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of microbial etiology by laboratory testing</measure>
    <time_frame>30 days following enrollment, although microbial identification usually occurs within 5 days.</time_frame>
    <description>POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum)</measure>
    <time_frame>30 days after enrollment although most patients will be evaluable within 5 days</time_frame>
    <description>Antiviral agents will be administered at POC (point-of-care) if Influenza virus is identified by molecular testing. Penicillin compounds will be administered if Strep pneumoniae is identified. Macrolides/quinolone will be administered if Mycoplasma pneumoniae and Legionella are identified. Etc.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of stay (LOS) for hospitalized patients</measure>
    <time_frame>30 days after enrollment</time_frame>
    <description>Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>Point-of-Care diagnostic laboratory test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empiric therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Option of no application of POC laboratory tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Point-of-Care diagnostic laboratory test</intervention_name>
    <description>All POC tests are FDA-cleared.</description>
    <arm_group_label>Point-of-Care diagnostic laboratory test</arm_group_label>
    <other_name>The POC tests are:</other_name>
    <other_name>FilmArray (Idaho Tech, Salt Lake City, UT)</other_name>
    <other_name>Xpert Flu (Cepheid, Sunnyvale, CA)</other_name>
    <other_name>Vidas Brahms Procalcitonin (BioMerieux, Durham, NC)</other_name>
    <other_name>Urinary antigen for Strep pneumoniae (Alere, Waltham, MA)</other_name>
    <other_name>Legionella BinaxNOW urinary antigen(Alere, Waltham, MA)</other_name>
    <other_name>Gram stain of respiratory secretions</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ● Adult patients greater than age 17 years who are initially evaluated in the ED with&#xD;
        symptoms of CAP. This includes those who will be treated as outpatients and those admitted&#xD;
        to the hospital (both ward and ICU).&#xD;
&#xD;
        The definition of CAP is as follows:&#xD;
&#xD;
          -  Presence of pulmonary infiltrates on chest radiography. (Initial reading may be&#xD;
             performed by the ED physician - but has to be confirmed by board certified radiologist&#xD;
             for inclusion in the study).&#xD;
&#xD;
          -  At least 2 of the following: new onset of cough, productive sputum, shortness of&#xD;
             breath, chest pain, fever &gt; 380C, abnormal chest auscultation, WBC &gt; 12,000 cells/mL.&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Read, signed, and dated informed consent document&#xD;
&#xD;
          -  Available for follow-up for the planned duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia,&#xD;
             transplant recipient, cystic fibrosis, receipt of immunosuppressive medications&#xD;
             including corticosteroids, (equivalent of prednisone &gt; 10 mg) cancer chemotherapy, or&#xD;
             anti-tumor necrosis factor agents.&#xD;
&#xD;
          -  Patients residing in long-term care facilities&#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>Victor L Yu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summa Health System</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community-acquired pneumonia</keyword>
  <keyword>Targeted strategy</keyword>
  <keyword>Empiric therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</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/NCT01662258
org study id: HHSN272201000040C
nct id: NCT01662258
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This is a prospective interventional study to assess laboratory testing which will identify
      the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent
      selection for patients with community acquired-pneumonia (CAP).

      Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with
      respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted
      narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to
      Empiric therapy in patients with viral pneumonia
The study will be conducted at five academic medical university sites with 7 hospitals.
      Empiric therapy is defined as selection of antibiotic therapy based on the 2007 ATS-IDSA
      guidelines in which broad-spectrum antibiotics are recommended, and microbial cause is
      uncertain
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration
time frame: 30 days after enrollment
description: Symptoms of sputum, cough, shortness of breath. Objective signs of deterioration: Acute Respiratory Distress Syndrome, empyema,nonpulmonary infection by infecting microbe, ICU admission, rehospitalization within 7 days following discharge
measure: Identification of microbial etiology by laboratory testing
time frame: 30 days following enrollment, although microbial identification usually occurs within 5 days.
description: POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.
measure: Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum)
time frame: 30 days after enrollment although most patients will be evaluable within 5 days
description: Antiviral agents will be administered at POC (point-of-care) if Influenza virus is identified by molecular testing. Penicillin compounds will be administered if Strep pneumoniae is identified. Macrolides/quinolone will be administered if Mycoplasma pneumoniae and Legionella are identified. Etc.
measure: Length of stay (LOS) for hospitalized patients
time frame: 30 days after enrollment
description: Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.
arm group label: Point-of-Care diagnostic laboratory test
arm group type: Experimental
description: Adult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests.
arm group label: Empiric therapy
arm group type: No Intervention
description: Option of no application of POC laboratory tests
intervention type: Device
intervention name: Point-of-Care diagnostic laboratory test
description: All POC tests are FDA-cleared.
arm group label: Point-of-Care diagnostic laboratory test
other name: The POC tests are:
other name: FilmArray (Idaho Tech, Salt Lake City, UT)
other name: Xpert Flu (Cepheid, Sunnyvale, CA)
other name: Vidas Brahms Procalcitonin (BioMerieux, Durham, NC)
other name: Urinary antigen for Strep pneumoniae (Alere, Waltham, MA)
other name: Legionella BinaxNOW urinary antigen(Alere, Waltham, MA)
other name: Gram stain of respiratory secretions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victor L Yu, M.D.
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pneumonia