<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/NCT04453540</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI101</org_study_id>
    <nct_id>NCT04453540</nct_id>
  </id_info>
  <brief_title>FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context</brief_title>
  <acronym>FAP-REA</acronym>
  <official_title>Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Reims University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</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 research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on&#xD;
      the management of patients hospitalized in ICU for severe respiratory disease.&#xD;
&#xD;
      During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more&#xD;
      complex as the biological, radiological and clinical criteria of covid-19 interfere with the&#xD;
      standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with&#xD;
      COVID-19 are at higher risk of developing other associated infections and thus, patients have&#xD;
      therefore often been treated with antibiotics, adequately or not, due to difficulty to&#xD;
      quickly identify the etiology of their symptoms with conventional methods.&#xD;
&#xD;
      In order to improve their treatment, both diagnostic and therapeutic, we set up a new&#xD;
      syndromic molecular test in our laboratories to accelerate and improve the pneumonia&#xD;
      management and antibiotic stewardship. This research will include 100 to 150 adult patients&#xD;
      hospitalized in ICU during the first half of 2020. It will take place within the Nancy&#xD;
      University Hospital and the Reims University Hospital, France.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</primary_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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic decision</measure>
    <time_frame>24 h following the FilmArray results</time_frame>
    <description>Antibiotic prescription modification following the FilmArray results as:&#xD;
No prescription&#xD;
No change in antibiotic utilization&#xD;
Antibiotic initiation&#xD;
Antibiotic escalation&#xD;
Antibiotic de-escalation&#xD;
Antibiotic discontinuation</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Infectious Disease</condition>
  <condition>Pneumonia</condition>
  <condition>Molecular Diagnosis</condition>
  <condition>Covid-19</condition>
  <condition>Antibiotic Stewardship</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FilmArray PCR on respiratory samples</intervention_name>
    <description>Molecular test performed on respiratory samples realized for microbiological routine testing as part of the care</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients followed in ICU at the hospitals of Nancy and Reims for severe respiratory&#xD;
        diseases during the first half of 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years affiliated to a social security system&#xD;
&#xD;
          -  Patients who have received complete information about the research and who have not&#xD;
             objected to the use of its data&#xD;
&#xD;
          -  Patients with suspected SARS-Cov-2 infection&#xD;
&#xD;
          -  Patients for which a FilmArray test has been realized on its respiratory samples&#xD;
             between 1st of March and 1st of July 2020.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <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/NCT04453540
org study id: 2020PI101
nct id: NCT04453540
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on
      the management of patients hospitalized in ICU for severe respiratory disease.

      During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more
      complex as the biological, radiological and clinical criteria of covid-19 interfere with the
      standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with
      COVID-19 are at higher risk of developing other associated infections and thus, patients have
      therefore often been treated with antibiotics, adequately or not, due to difficulty to
      quickly identify the etiology of their symptoms with conventional methods.

      In order to improve their treatment, both diagnostic and therapeutic, we set up a new
      syndromic molecular test in our laboratories to accelerate and improve the pneumonia
      management and antibiotic stewardship. This research will include 100 to 150 adult patients
      hospitalized in ICU during the first half of 2020. It will take place within the Nancy
      University Hospital and the Reims University Hospital, France.
observational model: Case-Only
time perspective: Retrospective
measure: Therapeutic decision
time frame: 24 h following the FilmArray results
description: Antibiotic prescription modification following the FilmArray results as:
No prescription
No change in antibiotic utilization
Antibiotic initiation
Antibiotic escalation
Antibiotic de-escalation
Antibiotic discontinuation
intervention type: Diagnostic Test
intervention name: FilmArray PCR on respiratory samples
description: Molecular test performed on respiratory samples realized for microbiological routine testing as part of the care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Communicable Diseases
mesh term: Infections