<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/NCT01723644</url>
  </required_header>
  <id_info>
    <org_study_id>RC12_0151</org_study_id>
    <nct_id>NCT01723644</nct_id>
  </id_info>
  <brief_title>Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia</brief_title>
  <acronym>CLINPCT</acronym>
  <official_title>CLINPCT Study: Clinical Reassessment Versus Procalcitonin-guided Algorithm in Order to Reduce Antibiotic Consumption in Community-acquired Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial&#xD;
      including adult patients admitted in the emergency department with community-acquired&#xD;
      pneumonia. The objective of this clinical trial is to compare two strategies: clinical&#xD;
      reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with&#xD;
      community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is&#xD;
      systematically started in the emergency department. The continuation, the discontinuation or&#xD;
      the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and&#xD;
      Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is&#xD;
      diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and&#xD;
      to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to&#xD;
      evaluate the possibility to stop the current antibiotherapy based on criteria for clinical&#xD;
      stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart&#xD;
      rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg,&#xD;
      Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm,&#xD;
      initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship&#xD;
      based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the&#xD;
      clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all&#xD;
      persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm&#xD;
      can be overruled by pre-specified criteria, e.g. in patients with immediately&#xD;
      life-threatening disease. If the algorithm is overruled and antibiotics are given, an early&#xD;
      discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on&#xD;
      PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are&#xD;
      reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs&#xD;
      defined above.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Other</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>duration of antibiotic therapy expressed in days of therapy</measure>
    <time_frame>Between Day 1 and Day 30</time_frame>
    <description>antibiotic duration is defined as all antibiotherapy prescribed for a community acquired pneumonia during the 30 day following period Safety Issue: Yes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical success at Day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>clinical success is defined as cure of the pneumonia at Day 30 Safety Issue: Clinical cure was defined as either the return to the pre-infection state (i.e. all pneumonia-related signs and symptoms had disappeared and chest X-ray findings had shown improvement) or improvement in related post-infectious stigmata, such that residual symptoms if any did not require additional treatment and were accompanied by improvement or lack of progression based on chest X-ray.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">286</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <arm_group>
    <arm_group_label>PCT guidance</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group of patient &quot; Procalcitonin &quot; where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clinical reassessment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the clinical reassessment arm</intervention_name>
    <description>In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America</description>
    <arm_group_label>clinical reassessment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the procalcitonin arm</intervention_name>
    <description>In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.</description>
    <arm_group_label>PCT guidance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  admittance from the community or a nursing home with the main diagnosis of&#xD;
             community-acquired pneumonia justifying urgent antibiotherapy prescription,&#xD;
             hospitalization for at least 6 hours after randomization and chest radiograph&#xD;
             compatible with the diagnosis of CAP( Community acquired pneumonia )&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  the inability to give written informed consent&#xD;
&#xD;
          -  hospitalization &gt;24 hours&#xD;
&#xD;
          -  aspiration pneumonia&#xD;
&#xD;
          -  nosocomial pneumonia&#xD;
&#xD;
          -  purulent pleurisy&#xD;
&#xD;
          -  exacerbation of COPD (chronic obstructive pulmonary disease)&#xD;
&#xD;
          -  neutropenia (&lt;1G/L cells)&#xD;
&#xD;
          -  chronic infection with current antibiotherapy&#xD;
&#xD;
          -  antibiotherapy before admission for the current infection&#xD;
&#xD;
          -  immunosuppression (including prolonged corticotherapy (10 mg of prednisone per day for&#xD;
             at least one month)&#xD;
&#xD;
          -  active neoplastic disease, organ transplant, pregnancy, HIV diagnosis with a CD4&#xD;
             count&lt;200 cells/μL.&#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>Emmanuel Montassier</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital of Agen</name>
      <address>
        <city>Agen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Clermont-Ferrand</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche sur Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Bichat Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Bobigny Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Hôtel-Dieu Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Saint Antoine Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>May 29, 2017</last_update_submitted>
  <last_update_submitted_qc>May 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>antibiotherapy, community acquired pneumonia, procalcitonin guided guidelines, clinical reassessment</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/NCT01723644
org study id: RC12_0151
nct id: NCT01723644
lead sponsor: 
has dmc: No
CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial
      including adult patients admitted in the emergency department with community-acquired
      pneumonia. The objective of this clinical trial is to compare two strategies: clinical
      reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with
      community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is
      systematically started in the emergency department. The continuation, the discontinuation or
      the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and
      Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is
      diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and
      to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to
      evaluate the possibility to stop the current antibiotherapy based on criteria for clinical
      stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart
      rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg,
      Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm,
      initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship
      based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the
      clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all
      persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm
      can be overruled by pre-specified criteria, e.g. in patients with immediately
      life-threatening disease. If the algorithm is overruled and antibiotics are given, an early
      discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on
      PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are
      reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs
      defined above.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Care Provider)
measure: duration of antibiotic therapy expressed in days of therapy
time frame: Between Day 1 and Day 30
description: antibiotic duration is defined as all antibiotherapy prescribed for a community acquired pneumonia during the 30 day following period Safety Issue: Yes
measure: clinical success at Day 30
time frame: Day 30
description: clinical success is defined as cure of the pneumonia at Day 30 Safety Issue: Clinical cure was defined as either the return to the pre-infection state (i.e. all pneumonia-related signs and symptoms had disappeared and chest X-ray findings had shown improvement) or improvement in related post-infectious stigmata, such that residual symptoms if any did not require additional treatment and were accompanied by improvement or lack of progression based on chest X-ray.
arm group label: PCT guidance
arm group type: Other
description: Group of patient " Procalcitonin " where the initiation and the stop of the antibiotic treatment are made according to a strategy guided by the PCT
arm group label: clinical reassessment
arm group type: Other
description: Group of patient where the initiation and the stop of the antibiotic treatment make following on clinical criteria and paraclinic not including the PCT.
intervention type: Other
intervention name: the clinical reassessment arm
description: In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America
arm group label: clinical reassessment
intervention type: Other
intervention name: the procalcitonin arm
description: In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.
arm group label: PCT guidance
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel Montassier
role: Principal Investigator
affiliation: CHU de Nantes
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia