<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/NCT03840603</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02173-52</org_study_id>
    <nct_id>NCT03840603</nct_id>
  </id_info>
  <brief_title>Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department</brief_title>
  <acronym>PROARRAY</acronym>
  <official_title>PROARRAY : Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioMérieux</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>APHP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BioFortis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BioMérieux</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The real-time reporting of PCT results along with viral PCR data from the FilmArray®&#xD;
      Respiratory Panel 2 plus in conjunction with an antimicrobial stewardship plan will aid in&#xD;
      the proper withholding or withdrawing of antibiotics (ATB) when the collective data is&#xD;
      indicative of a viral Lower Respiratory Tract Infection (LRTI).&#xD;
&#xD;
      The addition of the FilmArray® RP2plus diagnostic test indicating the presence of a viral&#xD;
      infection in subjects presenting with respiratory symptoms could improve the confidence to&#xD;
      care-providing physicians to withhold prescribing antibiotics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the emergency room a nasopharyngeal swab sample will be collected from subjects with a&#xD;
      suspected LRTI for the FilmArray respiratory panel assay plus a blood sample for the PCT&#xD;
      assay if the PCT measurement has not been already prescribed.&#xD;
&#xD;
      The FilmArray® Respiratory Panel 2 plus (RP2plus) is a multiplexed nucleic acid test intended&#xD;
      for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative&#xD;
      detection and identification of multiple respiratory viral and bacterial nucleic acids in&#xD;
      nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract&#xD;
      infections.&#xD;
&#xD;
      Both results will be reported in real-time to the treating physicians with the recommendation&#xD;
      to withhold or withdraw antibiotics if:&#xD;
&#xD;
        1. PCT&lt;0.10 µg/L with either a positive (with a viral respiratory pathogen) or negative&#xD;
           FilmArray assay or&#xD;
&#xD;
        2. PCT&lt;0.25 µg/L and FilmArray positive with a viral respiratory pathogen. For the control&#xD;
           arm, patients will benefit from the usual care of patients with suspected LRTI at the&#xD;
           discretion of the attending physician. Care may entail a CRP and/or a PCT measurement,&#xD;
           but no nasopharyngeal swab sampling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>
    <intervention_model_description>This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of total antibiotic exposure</measure>
    <time_frame>First 28 days</time_frame>
    <description>The primary endpoint in this study is the duration of total antibiotic exposure (measured in days) in the first 28 days after randomization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Initiation of an antibiotic therapy</measure>
    <time_frame>First 28 days</time_frame>
    <description>initiation of an antibiotic therapy in the first 28 days after the reporting test results to clinicians (both ATB given in the ED or given a prescription for an ATB to get at the pharmacy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protocol &quot;failure&quot; within 15 days of randomization</measure>
    <time_frame>within 15 days</time_frame>
    <description>protocol &quot;failure&quot; within 15 days of randomization (defined as worsening of LRTI and/or receipt of antibiotics in cases where no initial ATB treatment was administered, and/or unplanned ED's re-admission for the same complaint)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">444</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care of patients with suspected Low RespiratoryTract Infection at the discretion of the attending physician. Care may entail a CRP and/or a PCT measurement, but no nasopharyngeal swab sampling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Film Array RP2 Assay guided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the emergency room a nasopharyngeal swab sample will be collected from subjects with a suspected Low RespiratoryTract Infection for the Film Array RP2 Assay guided plus a blood sample for the PCT assay if the PCT measurement has not been already prescribed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Film Array RP2 Assay guided</intervention_name>
    <description>Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.</description>
    <arm_group_label>Film Array RP2 Assay guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Subject is ≥ 18 years of age attending the ED with LRTI symptom defined as at least&#xD;
             one among:&#xD;
&#xD;
               1. sweats, chills, body aches and pain, temperature &gt;38°C) and at least one among:&#xD;
&#xD;
               2. cough, sputum production, dyspnea, chest pain, altered breath sounds at&#xD;
                  auscultation.&#xD;
&#xD;
          -  2. Subject signs informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is a prisoner&#xD;
&#xD;
          2. Subject is a Pregnant&#xD;
&#xD;
          3. Subject has no social insurance&#xD;
&#xD;
          4. Subject is enrolled in end of life care&#xD;
&#xD;
          5. Subject refuses to participate in study procedures&#xD;
&#xD;
          6. Subject is already enrolled (each patient will only be tested one time with the&#xD;
             FilmArray® RP2plus)&#xD;
&#xD;
          7. Subject has a contraindication (per the discretion of the attending physician) to a&#xD;
             nasopharyngeal swab (for example, nose bone fracture or recent history of&#xD;
             maxilla-facial surgery)&#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>Pierre Hausfater</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Pitié-Salpêtrière, APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pierre Hausfater, Pr.</last_name>
    <phone>00 33 1 42 17 72 40</phone>
    <email>pierre.hausfater@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>AP-HP Pitié la salpétrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Albrich WC, Dusemund F, Bucher B, Meyer S, Thomann R, Kuhn F, Bassetti S, Sprenger M, Bachli E, Sigrist T, Schwietert M, Amin D, Hausfater P, Carre E, Gaillat J, Schuetz P, Regez K, Bossart R, Schild U, Mueller B; ProREAL Study Team. Effectiveness and safety of procalcitonin-guided antibiotic therapy in lower respiratory tract infections in &quot;real life&quot;: an international, multicenter poststudy survey (ProREAL). Arch Intern Med. 2012 May 14;172(9):715-22. doi: 10.1001/archinternmed.2012.770. Erratum In: Arch Intern Med. 2014 Jun;174(6):1011.</citation>
    <PMID>22782201</PMID>
  </reference>
  <reference>
    <citation>Branche AR, Walsh EE, Vargas R, Hulbert B, Formica MA, Baran A, Peterson DR, Falsey AR. Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial. J Infect Dis. 2015 Dec 1;212(11):1692-700. doi: 10.1093/infdis/jiv252. Epub 2015 Apr 24.</citation>
    <PMID>25910632</PMID>
  </reference>
  <reference>
    <citation>Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.</citation>
    <PMID>25704448</PMID>
  </reference>
  <reference>
    <citation>Woodhead M, Blasi F, Ewig S, Garau J, Huchon G, Ieven M, Ortqvist A, Schaberg T, Torres A, van der Heijden G, Read R, Verheij TJ; Joint Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases. Guidelines for the management of adult lower respiratory tract infections--full version. Clin Microbiol Infect. 2011 Nov;17 Suppl 6(Suppl 6):E1-59. doi: 10.1111/j.1469-0691.2011.03672.x.</citation>
    <PMID>21951385</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Respiratory Tract Infections</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Procalcitonin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Emergencies</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/NCT03840603
org study id: 2018-A02173-52
nct id: NCT03840603
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The real-time reporting of PCT results along with viral PCR data from the FilmArray®
      Respiratory Panel 2 plus in conjunction with an antimicrobial stewardship plan will aid in
      the proper withholding or withdrawing of antibiotics (ATB) when the collective data is
      indicative of a viral Lower Respiratory Tract Infection (LRTI).

      The addition of the FilmArray® RP2plus diagnostic test indicating the presence of a viral
      infection in subjects presenting with respiratory symptoms could improve the confidence to
      care-providing physicians to withhold prescribing antibiotics.
In the emergency room a nasopharyngeal swab sample will be collected from subjects with a
      suspected LRTI for the FilmArray respiratory panel assay plus a blood sample for the PCT
      assay if the PCT measurement has not been already prescribed.

      The FilmArray® Respiratory Panel 2 plus (RP2plus) is a multiplexed nucleic acid test intended
      for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative
      detection and identification of multiple respiratory viral and bacterial nucleic acids in
      nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract
      infections.

      Both results will be reported in real-time to the treating physicians with the recommendation
      to withhold or withdraw antibiotics if:

        1. PCT<0.10 µg/L with either a positive (with a viral respiratory pathogen) or negative
           FilmArray assay or

        2. PCT<0.25 µg/L and FilmArray positive with a viral respiratory pathogen. For the control
           arm, patients will benefit from the usual care of patients with suspected LRTI at the
           discretion of the attending physician. Care may entail a CRP and/or a PCT measurement,
           but no nasopharyngeal swab sampling.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is an open label, prospective, single-center, randomized interventional trial with 2 arms (FilmArray-guided arm versus usual care).
primary purpose: Diagnostic
masking: Single (Participant)
measure: Duration of total antibiotic exposure
time frame: First 28 days
description: The primary endpoint in this study is the duration of total antibiotic exposure (measured in days) in the first 28 days after randomization.
measure: Initiation of an antibiotic therapy
time frame: First 28 days
description: initiation of an antibiotic therapy in the first 28 days after the reporting test results to clinicians (both ATB given in the ED or given a prescription for an ATB to get at the pharmacy)
measure: Protocol "failure" within 15 days of randomization
time frame: within 15 days
description: protocol "failure" within 15 days of randomization (defined as worsening of LRTI and/or receipt of antibiotics in cases where no initial ATB treatment was administered, and/or unplanned ED's re-admission for the same complaint)
arm group label: Control
arm group type: No Intervention
description: Usual care of patients with suspected Low RespiratoryTract Infection at the discretion of the attending physician. Care may entail a CRP and/or a PCT measurement, but no nasopharyngeal swab sampling.
arm group label: Film Array RP2 Assay guided
arm group type: Experimental
description: In the emergency room a nasopharyngeal swab sample will be collected from subjects with a suspected Low RespiratoryTract Infection for the Film Array RP2 Assay guided plus a blood sample for the PCT assay if the PCT measurement has not been already prescribed.
intervention type: Diagnostic Test
intervention name: Film Array RP2 Assay guided
description: Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.
arm group label: Film Array RP2 Assay guided
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Hausfater
role: Principal Investigator
affiliation: Hôpital Pitié-Salpêtrière, APHP
last name: Pierre Hausfater, Pr.
phone: 00 33 1 42 17 72 40
email: pierre.hausfater@aphp.fr
facility: 
status: Recruiting
country: France
citation: Albrich WC, Dusemund F, Bucher B, Meyer S, Thomann R, Kuhn F, Bassetti S, Sprenger M, Bachli E, Sigrist T, Schwietert M, Amin D, Hausfater P, Carre E, Gaillat J, Schuetz P, Regez K, Bossart R, Schild U, Mueller B; ProREAL Study Team. Effectiveness and safety of procalcitonin-guided antibiotic therapy in lower respiratory tract infections in "real life": an international, multicenter poststudy survey (ProREAL). Arch Intern Med. 2012 May 14;172(9):715-22. doi: 10.1001/archinternmed.2012.770. Erratum In: Arch Intern Med. 2014 Jun;174(6):1011.
PMID: 22782201
citation: Branche AR, Walsh EE, Vargas R, Hulbert B, Formica MA, Baran A, Peterson DR, Falsey AR. Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial. J Infect Dis. 2015 Dec 1;212(11):1692-700. doi: 10.1093/infdis/jiv252. Epub 2015 Apr 24.
PMID: 25910632
citation: Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.
PMID: 25704448
citation: Woodhead M, Blasi F, Ewig S, Garau J, Huchon G, Ieven M, Ortqvist A, Schaberg T, Torres A, van der Heijden G, Read R, Verheij TJ; Joint Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases. Guidelines for the management of adult lower respiratory tract infections--full version. Clin Microbiol Infect. 2011 Nov;17 Suppl 6(Suppl 6):E1-59. doi: 10.1111/j.1469-0691.2011.03672.x.
PMID: 21951385
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
mesh term: Emergencies
sharing ipd: No