<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/NCT03763799</url>
  </required_header>
  <id_info>
    <org_study_id>2018_40</org_study_id>
    <secondary_id>2018-A02219-46</secondary_id>
    <nct_id>NCT03763799</nct_id>
  </id_info>
  <brief_title>Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation</brief_title>
  <acronym>APAPI</acronym>
  <official_title>Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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 two most common consequences resulting from aspiration are chemical pneumonitis and&#xD;
      bacterial aspiration pneumonia. Both entities present with comparable clinical signs and&#xD;
      symptoms. In the absence of a reliable clinical or biological marker to differentiate between&#xD;
      these two conditions, most patients with suspected aspiration are treated empirically with&#xD;
      antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results&#xD;
      of microbiological results, usually performed before starting antimicrobial treatment.&#xD;
      However, in most hospitals, 48-72h are required to obtain the results of microbiological&#xD;
      cultures, and to de-escalate empirical large spectrum antibiotic treatment.&#xD;
&#xD;
      The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory&#xD;
      bacterial pathogens would allow decreasing the percentage of patients with aspiration&#xD;
      syndrome who will receive unappropriated antibiotic treatment at Day 3.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 20, 2019</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">December 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment</measure>
    <time_frame>48 hours after antibiotic treatment initiation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the percentage of patients who will receive appropriate antibiotic treatment.</measure>
    <time_frame>at Day 28 and Day 90 after antibiotic treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the percentage of patients who will receive targeted antibiotic treatment.</measure>
    <time_frame>at Day 28 and Day 90 after antibiotic treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanical ventilation free days.</measure>
    <time_frame>at Day 28 and Day 90 after antibiotic treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of ICU stay.</measure>
    <time_frame>up to Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality.</measure>
    <time_frame>up to Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>antibiotic free days.</measure>
    <time_frame>up to Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)</measure>
    <time_frame>at Day 28 and Day 90 after antibiotic treatment initiation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">266</enrollment>
  <condition>Aspiration Pneumonia</condition>
  <arm_group>
    <arm_group_label>multiplex PCR strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FilmArray® Pneumonia Panel plus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PCR-based microbiological diagnosis strategy</intervention_name>
    <description>A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation</description>
    <arm_group_label>multiplex PCR strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard microbiological diagnosis strategy</intervention_name>
    <description>Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation</description>
    <arm_group_label>standard strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of risk factors for aspiration :&#xD;
&#xD;
          -  known or likely swallowing dysfunction,&#xD;
&#xD;
          -  altered consciousness,&#xD;
&#xD;
          -  cardiac arrest,&#xD;
&#xD;
          -  difficult intubation&#xD;
&#xD;
          -  witnessed aspiration&#xD;
&#xD;
          -  symptoms and signs suggestive of lower respiratory tract pathology&#xD;
&#xD;
          -  temperature ≥38.5°C or &lt;36°C&#xD;
&#xD;
          -  leukocyte count ≥10 000/µL or &lt;1500/µL&#xD;
&#xD;
          -  purulent sputum or tracheal aspirate.&#xD;
&#xD;
          -  new radiographic infiltrate on chest X-ray&#xD;
&#xD;
          -  tracheal intubation and mechanical ventilation since less than 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  refuse to participate to the study&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  documented bacteremia&#xD;
&#xD;
          -  septic shock&#xD;
&#xD;
          -  severe immunosuppression: leukocytes&lt;1000/L or neutrophils&lt;500/L, chemotherapy during&#xD;
             the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4&lt;50),&#xD;
             and chronic corticosteroid use (&gt;0.5 mg/kg day for at least one month during the last&#xD;
             three months).&#xD;
&#xD;
          -  moribund patients (SAPS II &gt;90).&#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>Saadalla NSEIR, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Saadalla NSEIR, MD,PhD</last_name>
    <phone>03 20 44 44 95</phone>
    <phone_ext>+33</phone_ext>
    <email>Saadalla.NSEIR@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Roger Salengro, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Saad Nseir</last_name>
      <phone>33320444495</phone>
      <email>s-nseir@chru-lille.fr</email>
    </contact>
    <investigator>
      <last_name>Saad Nseir, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aspiration pneumonia</keyword>
  <keyword>Invasive ventilation</keyword>
  <keyword>PCR</keyword>
  <keyword>Antibiotics</keyword>
  <keyword>Tracheal aspirate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Aspiration</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/NCT03763799
org study id: 2018_40
secondary id: 2018-A02219-46
nct id: NCT03763799
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The two most common consequences resulting from aspiration are chemical pneumonitis and
      bacterial aspiration pneumonia. Both entities present with comparable clinical signs and
      symptoms. In the absence of a reliable clinical or biological marker to differentiate between
      these two conditions, most patients with suspected aspiration are treated empirically with
      antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results
      of microbiological results, usually performed before starting antimicrobial treatment.
      However, in most hospitals, 48-72h are required to obtain the results of microbiological
      cultures, and to de-escalate empirical large spectrum antibiotic treatment.

      The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory
      bacterial pathogens would allow decreasing the percentage of patients with aspiration
      syndrome who will receive unappropriated antibiotic treatment at Day 3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
time frame: 48 hours after antibiotic treatment initiation
measure: the percentage of patients who will receive appropriate antibiotic treatment.
time frame: at Day 28 and Day 90 after antibiotic treatment initiation
measure: the percentage of patients who will receive targeted antibiotic treatment.
time frame: at Day 28 and Day 90 after antibiotic treatment initiation
measure: mechanical ventilation free days.
time frame: at Day 28 and Day 90 after antibiotic treatment initiation
measure: length of ICU stay.
time frame: up to Day 90
measure: ICU mortality.
time frame: up to Day 90
measure: antibiotic free days.
time frame: up to Day 90
measure: percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)
time frame: at Day 28 and Day 90 after antibiotic treatment initiation
arm group label: multiplex PCR strategy
arm group type: Experimental
description: FilmArray® Pneumonia Panel plus
arm group label: standard strategy
arm group type: Active Comparator
intervention type: Procedure
intervention name: PCR-based microbiological diagnosis strategy
description: A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
arm group label: multiplex PCR strategy
intervention type: Procedure
intervention name: Standard microbiological diagnosis strategy
description: Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
arm group label: standard strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Saadalla NSEIR, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Saadalla NSEIR, MD,PhD
phone: 03 20 44 44 95
phone ext: +33
email: Saadalla.NSEIR@chru-lille.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Aspiration