<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/NCT02261610</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0203</org_study_id>
    <secondary_id>2014-A00046-41</secondary_id>
    <nct_id>NCT02261610</nct_id>
  </id_info>
  <brief_title>Pulmonary Embolism and PCT. PE-PCT Study</brief_title>
  <official_title>Interest of PCT in the Management of Antibiotic for the Patient With a Febrile Pulmonary Embolism.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thermo Fisher Scientific, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      The clinical manifestations of pulmonary embolism vary greatly from the absence of specific&#xD;
      clinical symptoms to cardiogenic shock or cardiac arrest. Clinical form of EP represented by&#xD;
      &quot;lung superinfection&quot;, also called &quot;pulmonary embolism superinfected&quot; is common and&#xD;
      represents up to 30% of initial clinical presentations; she been few evaluations in clinical&#xD;
      research. The reality of the bacterial infection remains controversial and the clinical&#xD;
      presentation often leads to the prescription of empirical antibiotic therapy, often&#xD;
      unnecessary in many cases. Number of antibiotic prescriptions are probably inappropriate.&#xD;
&#xD;
      Fever has long been recognized as a sign associated with pulmonary embolism. Stein et al&#xD;
      reported a temperature above 37.5 ° C on 50% of patients with acute pulmonary embolism&#xD;
      without actually clarified whether this was related to temperature with a pulmonary embolism&#xD;
      or other associated cause. Murray et al estimated that greater than 38 ° C was explained by&#xD;
      pulmonary embolism in 57.1% of patients while in the PIOPED study, only 14% of patients had&#xD;
      fever with no other cause identified as pulmonary embolism. Fever due to pulmonary embolism&#xD;
      is often low intensity (often less than 38.3) and of short duration, with a peak on the day&#xD;
      of pulmonary embolism and a gradual decrease of about 1 week. The pathophysiology of fever in&#xD;
      pulmonary embolism has not yet was completely clarified. It is suggested that a combination&#xD;
      of several factors involved pyrogenic myocardial tissue necrosis and releasing&#xD;
      pro-inflammatory cytokines, hemorrhage, vascular irritation or inflammation, atelectasis or&#xD;
      local superinfection.&#xD;
&#xD;
      Since 2004, the PCT has become a marker helping the initiation of antibiotic therapy in&#xD;
      patients with community-acquired pneumonia. This is especially verified in patients admitted&#xD;
      for acute exacerbation of chronic obstructive bronchitis. In the latter case, the use of PCT&#xD;
      reduces inappropriate antibiotic prescribing. Thus helping the clinician by measuring&#xD;
      biomarkers such as PCT is based on writing an algorithm leading or not to use antibiotics.&#xD;
&#xD;
      The use of an algorithm involving the PCT could just as for infectious pneumonia or COPD, of&#xD;
      interest in the febrile pulmonary embolism to distinguish febrile forms related to bacterial&#xD;
      infections febrile forms of EP to other causes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to realize a single-center prospective, randomized, parallel group,&#xD;
      to compare two groups of patients admitted with febrile pulmonary embolism . In the first&#xD;
      group of patients, the use of antibiotics will be guided by clinical (clinical group). In the&#xD;
      second group, the use of antibiotics will be guided by the algorithm (PCT group). The guided&#xD;
      by the PCT algorithm is only given aid the clinician in the therapeutic management without&#xD;
      its application only requires the doctor in charge of the patient. So if your doctor may&#xD;
      advocate (or deemed necessary) to continue (or start) antibiotics even if the PCT algorithm&#xD;
      would allow him to stop (or not initiate).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficulty of recrutement&#xD;
  </why_stopped>
  <start_date type="Actual">November 26, 2014</start_date>
  <completion_date type="Actual">November 24, 2019</completion_date>
  <primary_completion_date type="Actual">July 24, 2019</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>Percentage of patient treated by antibiotics in each group</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of death</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of antibiotics stop</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of new hospitalization during the following month</measure>
    <time_frame>at 1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Pulmonary Embolism With Fever</condition>
  <arm_group>
    <arm_group_label>clinical group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first group of patients, the use of antibiotics will be guided by clinical (clinical group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCT group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the second group, the use of antibiotics will be guided by the algorithm (PCT group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Procalcitonin algorithm</intervention_name>
    <description>Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy</description>
    <arm_group_label>PCT group</arm_group_label>
    <arm_group_label>clinical group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  CT diagnosis of pulmonary embolism&#xD;
&#xD;
          -  Temperature&gt; 37.8 ° C&#xD;
&#xD;
          -  About affiliated to the social security&#xD;
&#xD;
          -  Prior agreement with the patient signing a consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Woman&#xD;
&#xD;
          -  Refusal of the patient&#xD;
&#xD;
          -  Pulmonary Neoplasia&#xD;
&#xD;
          -  Antibiotic ongoing for more than 24 hours at the time of diagnosis of pulmonary&#xD;
             embolism&#xD;
&#xD;
          -  Cardiogenic shock (hypotension with mean arterial pressure less than 65 bpm)&#xD;
&#xD;
          -  Suspicion of infection other than lung associated (associated urinary tract infection,&#xD;
             prostatitis, ENT infection, sinusitis ...)&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Patients unable to give consent&#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>Farès MOUSTAFA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>April 1, 2021</last_update_submitted>
  <last_update_submitted_qc>April 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PCT algorithm</keyword>
  <keyword>Antibiotic</keyword>
  <keyword>Pulmonary embolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</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/NCT02261610
org study id: CHU-0203
secondary id: 2014-A00046-41
nct id: NCT02261610
lead sponsor: 
collaborator: 
The clinical manifestations of pulmonary embolism vary greatly from the absence of specific
      clinical symptoms to cardiogenic shock or cardiac arrest. Clinical form of EP represented by
      "lung superinfection", also called "pulmonary embolism superinfected" is common and
      represents up to 30% of initial clinical presentations; she been few evaluations in clinical
      research. The reality of the bacterial infection remains controversial and the clinical
      presentation often leads to the prescription of empirical antibiotic therapy, often
      unnecessary in many cases. Number of antibiotic prescriptions are probably inappropriate.

      Fever has long been recognized as a sign associated with pulmonary embolism. Stein et al
      reported a temperature above 37.5 ° C on 50% of patients with acute pulmonary embolism
      without actually clarified whether this was related to temperature with a pulmonary embolism
      or other associated cause. Murray et al estimated that greater than 38 ° C was explained by
      pulmonary embolism in 57.1% of patients while in the PIOPED study, only 14% of patients had
      fever with no other cause identified as pulmonary embolism. Fever due to pulmonary embolism
      is often low intensity (often less than 38.3) and of short duration, with a peak on the day
      of pulmonary embolism and a gradual decrease of about 1 week. The pathophysiology of fever in
      pulmonary embolism has not yet was completely clarified. It is suggested that a combination
      of several factors involved pyrogenic myocardial tissue necrosis and releasing
      pro-inflammatory cytokines, hemorrhage, vascular irritation or inflammation, atelectasis or
      local superinfection.

      Since 2004, the PCT has become a marker helping the initiation of antibiotic therapy in
      patients with community-acquired pneumonia. This is especially verified in patients admitted
      for acute exacerbation of chronic obstructive bronchitis. In the latter case, the use of PCT
      reduces inappropriate antibiotic prescribing. Thus helping the clinician by measuring
      biomarkers such as PCT is based on writing an algorithm leading or not to use antibiotics.

      The use of an algorithm involving the PCT could just as for infectious pneumonia or COPD, of
      interest in the febrile pulmonary embolism to distinguish febrile forms related to bacterial
      infections febrile forms of EP to other causes.
The investigators propose to realize a single-center prospective, randomized, parallel group,
      to compare two groups of patients admitted with febrile pulmonary embolism . In the first
      group of patients, the use of antibiotics will be guided by clinical (clinical group). In the
      second group, the use of antibiotics will be guided by the algorithm (PCT group). The guided
      by the PCT algorithm is only given aid the clinician in the therapeutic management without
      its application only requires the doctor in charge of the patient. So if your doctor may
      advocate (or deemed necessary) to continue (or start) antibiotics even if the PCT algorithm
      would allow him to stop (or not initiate).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percentage of patient treated by antibiotics in each group
time frame: at day 1
measure: Percentage of death
time frame: at day 1
measure: Percentage of antibiotics stop
time frame: at day 1
measure: Rate of new hospitalization during the following month
time frame: at 1 month
arm group label: clinical group
arm group type: Experimental
description: In the first group of patients, the use of antibiotics will be guided by clinical (clinical group).
arm group label: PCT group
arm group type: Other
description: In the second group, the use of antibiotics will be guided by the algorithm (PCT group).
intervention type: Procedure
intervention name: Procalcitonin algorithm
description: Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy
arm group label: PCT group
arm group label: clinical group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farès MOUSTAFA
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Embolism