<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/NCT02244723</url>
  </required_header>
  <id_info>
    <org_study_id>VPLUS</org_study_id>
    <nct_id>NCT02244723</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia</brief_title>
  <acronym>VPLUS</acronym>
  <official_title>Prospective, Observational Study of Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by&#xD;
      mechanically-ventilated patients in the intensive care unit (ICU). It has significant&#xD;
      clinical and economic consequences, as it is associated with considerable morbidity,&#xD;
      increased mortality, and excess health care costs. Appropriate antibiotic therapy for&#xD;
      patients with VAP significantly improves outcomes, making rapid identification of patients&#xD;
      with VAP an important clinical goal.&#xD;
&#xD;
      This application is for support of a prospective, multi-centered study to evaluate the&#xD;
      diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association&#xD;
      of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could&#xD;
      allow for early and reliable diagnosis of bacterial VAP.&#xD;
&#xD;
      Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung&#xD;
      ultrasound alone and in association with the CPIS.&#xD;
&#xD;
      Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural&#xD;
      consolidation, irregular B-lines) in VAP.&#xD;
&#xD;
      Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung&#xD;
      ultrasound, and unprotected tracheal aspirate (UTA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be enrolled within 24 hours of the point at which criteria are met for&#xD;
      suspected VAP. Upon enrollment, the following variables will be recorded from the online&#xD;
      medical record, and a Clinical Pulmonary Infection Score will be calculated.&#xD;
&#xD;
        -  Demographics (height, weight, comorbidities)&#xD;
&#xD;
        -  Ventilation parameters&#xD;
&#xD;
        -  Infectious disease data during present admission (antibiotic history, culture data)&#xD;
&#xD;
        -  Biochemical data (WBC count with differential, arterial blood gas)&#xD;
&#xD;
        -  Microbiological data (UTA and BAL) - UTA data must have been collected within 24 hours&#xD;
           of enrollment and BAL data within 12 hours of enrollment&#xD;
&#xD;
        -  Radiological data (CXR or chest CT)&#xD;
&#xD;
      Lung ultrasound will be performed within 24 hours of the point at which criteria are met for&#xD;
      suspected VAP. Lung ultrasound will include examination of both lungs. Each hemithorax will&#xD;
      be divided into three regions using anterior and posterior axillary lines as landmarks. Each&#xD;
      of these regions will be further divided into upper and lower quadrants, yielding a total of&#xD;
      6 quadrants per hemithorax. Examination will specifically identify the presence or absence of&#xD;
      the following lung ultrasound findings: normal pleural A lines, non-coalescent B lines,&#xD;
      coalescent B lines, consolidations (subpleural or lobar), and linear air bronchograms. A Lung&#xD;
      Ultrasound Aeration Score will be calculated based on these findings. Ultrasonographic&#xD;
      diagnosis of VAP will be defined based on the presence of subpleural consolidation, entire&#xD;
      lobar consolidation, or air bronchogram within consolidation.&#xD;
&#xD;
      The results of microbiological data will be followed up for confirmation of culture results.&#xD;
      Cultures will be considered positive if ≥ 100,000 bacterial colony-forming units (cfu) are&#xD;
      isolated.&#xD;
&#xD;
      At day #28 of study enrollment, the patient's status will be documented (alive vs. deceased,&#xD;
      inpatient vs. discharged).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2013</start_date>
  <completion_date type="Actual">September 1, 2015</completion_date>
  <primary_completion_date type="Actual">January 1, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ventilator-associated pneumonia.</measure>
    <time_frame>up to 30days</time_frame>
    <description>Ventilator associated pneumonia is diagnosed when patient has a positive broncho alveolar lavage (positive cultiure &gt;10*3 CFU/ml) and clinical criteria (◦Body temperature ≥ 38.5° C (101° F) or &lt; 36° C (97° F)&#xD;
White blood cell count &gt; 10,000/ml or &lt; 4,000/ml or &gt; 10% immature cells&#xD;
Partial pressure of oxygen in arterial blood &lt; 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio &lt; 300&#xD;
Purulent respiratory secretion)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of stay in ICU</measure>
    <time_frame>up to 60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital say</measure>
    <time_frame>up to 60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose ventilator-associated pneumonia</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with the CPIS to diagnose ventilator-associated pneumonia</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with unprotected tracheal aspirate to diagnose ventilator-associated pneumonia</measure>
    <time_frame>up to 30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">98</enrollment>
  <condition>Ventilator-Associated Pneumonia</condition>
  <arm_group>
    <arm_group_label>Patients with suspected VAP</arm_group_label>
    <description>Only one group is studied : mechanically-ventilated patients with suspected VAP in ICUs.&#xD;
For each patient a lung ultrasound examination will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lung ultrasound examination</intervention_name>
    <description>Lung ultrasound (LUS) is increasingly being used at the bedside for assessing alveolar-interstitial syndrome, lung consolidation, pneumonia, pneumothorax, and pleural effusion. It could be an easily repeatable noninvasive tool for diagnosis of ventilator associated pneumonia</description>
    <arm_group_label>Patients with suspected VAP</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Biochemical data (WBC count with differential, arterial blood gas)&#xD;
&#xD;
        -  Microbiological data (UTA and BAL) - UTA data must have been collected within 24 hours&#xD;
           of enrollment and BAL data within 12 hours of enrollment (unprotected tracheal aspirate&#xD;
           (UTA)- fibrobronchoscopy with protected distal sampling)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        subjects will be recruited from mechanically-ventilated patients with suspected VAP in ICUs&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mechanical ventilation for at least 48 hours,&#xD;
&#xD;
          -  New or evolving infiltrate on chest radiograph (CXR) or computed tomography (CT), and&#xD;
&#xD;
          -  A minimum of two of the following clinical criteria:&#xD;
&#xD;
               -  Body temperature ≥ 38.5° C (101° F) or &lt; 36° C (97° F)&#xD;
&#xD;
               -  White blood cell count &gt; 10,000/ml or &lt; 4,000/ml or &gt; 10% immature cells&#xD;
&#xD;
               -  Partial pressure of oxygen in arterial blood &lt; 60 mmHg or partial pressure of&#xD;
                  oxygen in arterial blood/ inspired oxygen fraction ratio &lt; 300&#xD;
&#xD;
               -  Purulent respiratory secretions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Known ongoing pneumonia&#xD;
&#xD;
          -  Patient younger than 18 years old&#xD;
&#xD;
          -  Mechanical ventilation &lt;48 hours&#xD;
&#xD;
          -  Contraindication to bronchoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>GH Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rianimazione I, (Dipartement of Anesthesia and Intensive Care Unit) of Fondazione IRCCS Policlinico S. Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.</citation>
    <PMID>19633538</PMID>
  </reference>
  <reference>
    <citation>Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.</citation>
    <PMID>20851923</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2013</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondation Hôpital Saint-Joseph</investigator_affiliation>
    <investigator_full_name>bélaid BOUHEMAD</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Ventilator-Associated Pneumonia</keyword>
  <keyword>diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Ventilator-Associated</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02244723
org study id: VPLUS
nct id: NCT02244723
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by
      mechanically-ventilated patients in the intensive care unit (ICU). It has significant
      clinical and economic consequences, as it is associated with considerable morbidity,
      increased mortality, and excess health care costs. Appropriate antibiotic therapy for
      patients with VAP significantly improves outcomes, making rapid identification of patients
      with VAP an important clinical goal.

      This application is for support of a prospective, multi-centered study to evaluate the
      diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association
      of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could
      allow for early and reliable diagnosis of bacterial VAP.

      Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung
      ultrasound alone and in association with the CPIS.

      Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural
      consolidation, irregular B-lines) in VAP.

      Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung
      ultrasound, and unprotected tracheal aspirate (UTA).
Patients will be enrolled within 24 hours of the point at which criteria are met for
      suspected VAP. Upon enrollment, the following variables will be recorded from the online
      medical record, and a Clinical Pulmonary Infection Score will be calculated.

        -  Demographics (height, weight, comorbidities)

        -  Ventilation parameters

        -  Infectious disease data during present admission (antibiotic history, culture data)

        -  Biochemical data (WBC count with differential, arterial blood gas)

        -  Microbiological data (UTA and BAL) - UTA data must have been collected within 24 hours
           of enrollment and BAL data within 12 hours of enrollment

        -  Radiological data (CXR or chest CT)

      Lung ultrasound will be performed within 24 hours of the point at which criteria are met for
      suspected VAP. Lung ultrasound will include examination of both lungs. Each hemithorax will
      be divided into three regions using anterior and posterior axillary lines as landmarks. Each
      of these regions will be further divided into upper and lower quadrants, yielding a total of
      6 quadrants per hemithorax. Examination will specifically identify the presence or absence of
      the following lung ultrasound findings: normal pleural A lines, non-coalescent B lines,
      coalescent B lines, consolidations (subpleural or lobar), and linear air bronchograms. A Lung
      Ultrasound Aeration Score will be calculated based on these findings. Ultrasonographic
      diagnosis of VAP will be defined based on the presence of subpleural consolidation, entire
      lobar consolidation, or air bronchogram within consolidation.

      The results of microbiological data will be followed up for confirmation of culture results.
      Cultures will be considered positive if ≥ 100,000 bacterial colony-forming units (cfu) are
      isolated.

      At day #28 of study enrollment, the patient's status will be documented (alive vs. deceased,
      inpatient vs. discharged).
observational model: Cohort
time perspective: Prospective
measure: ventilator-associated pneumonia.
time frame: up to 30days
description: Ventilator associated pneumonia is diagnosed when patient has a positive broncho alveolar lavage (positive cultiure >10*3 CFU/ml) and clinical criteria (◦Body temperature ≥ 38.5° C (101° F) or < 36° C (97° F)
White blood cell count > 10,000/ml or < 4,000/ml or > 10% immature cells
Partial pressure of oxygen in arterial blood < 60 mmHg or partial pressure of oxygen in arterial blood/ inspired oxygen fraction ratio < 300
Purulent respiratory secretion)
measure: Duration of stay in ICU
time frame: up to 60 days
measure: Duration of hospital say
time frame: up to 60 days
measure: Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose ventilator-associated pneumonia
time frame: up to 30 days
measure: sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with the CPIS to diagnose ventilator-associated pneumonia
time frame: up to 30 days
measure: sensitivity, specificity, and diagnostic accuracy of lung ultrasound in association with unprotected tracheal aspirate to diagnose ventilator-associated pneumonia
time frame: up to 30 days
arm group label: Patients with suspected VAP
description: Only one group is studied : mechanically-ventilated patients with suspected VAP in ICUs.
For each patient a lung ultrasound examination will be performed.
intervention type: Other
intervention name: Lung ultrasound examination
description: Lung ultrasound (LUS) is increasingly being used at the bedside for assessing alveolar-interstitial syndrome, lung consolidation, pneumonia, pneumothorax, and pleural effusion. It could be an easily repeatable noninvasive tool for diagnosis of ventilator associated pneumonia
arm group label: Patients with suspected VAP
-  Biochemical data (WBC count with differential, arterial blood gas)

        -  Microbiological data (UTA and BAL) - UTA data must have been collected within 24 hours
           of enrollment and BAL data within 12 hours of enrollment (unprotected tracheal aspirate
           (UTA)- fibrobronchoscopy with protected distal sampling)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
country: Italy
citation: Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.
PMID: 19633538
citation: Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
PMID: 20851923
responsible party type: Principal Investigator
investigator affiliation: Fondation Hôpital Saint-Joseph
investigator full name: bélaid BOUHEMAD
investigator title: M.D.
mesh term: Pneumonia
mesh term: Pneumonia, Ventilator-Associated
sharing ipd: Undecided