<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/NCT03833102</url>
  </required_header>
  <id_info>
    <org_study_id>35RC17_9726_PROSAC</org_study_id>
    <nct_id>NCT03833102</nct_id>
  </id_info>
  <brief_title>Prospective Study of Staphylococcus Aureus Clinical Isolates Versus Colonization: RNAs as Potential Biomarkers for Bloodstream Infections</brief_title>
  <acronym>PROSAC</acronym>
  <official_title>Prospective Study of Staphylococcus Aureus Clinical Isolates Versus Colonization: RNAs as Potential Biomarkers for Bloodstream Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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 primary objective is to demonstrate that the risk of S. aureus bacteremia (SAB) is&#xD;
      correlated to the RNA III and SprD RNAs expression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Staphylococcus aureus ranks among the top three organisms for community-acquired,&#xD;
      healthcare-related and nosocomial infections in humans. It lives as a commensal organism but&#xD;
      can also provoke very severe diseases. Identifying markers of the 'colonization/disease'&#xD;
      transition is of paramount importance. We recently found that an association of two&#xD;
      regulatory RNAs was associated with S. aureus infection rather than colonization and with the&#xD;
      severity of infection. Those preliminary results have to be confirmed with a more important&#xD;
      prospective cohort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2018</start_date>
  <completion_date type="Actual">February 22, 2023</completion_date>
  <primary_completion_date type="Actual">November 22, 2022</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>Levels of RNAIII expression and sprD in isolated strains of S. aureus from bacteremia</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Levels of expression of RNAIII and sprD in isolated strains of S. aureus isolated from bacteremia, compared to these same levels of expression in strains from colonized, uninfected patients.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">165</enrollment>
  <condition>Staphylococcus Aureus</condition>
  <arm_group>
    <arm_group_label>Colonized patients' group (CPG)</arm_group_label>
    <description>all adult patients hospitalized in or consulting the Rennes University Hospital, known as S. aureus colonized could be included. In our institution, S. aureus colonization in the nostrils is screened in all patients supposed to undergo neurosurgical or orthopedic surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAB patients' group (SAB)</arm_group_label>
    <description>all adult patients with SAB could be included. S. aureus colonization in the nostrils will be systematically screened immediately after the first result of positive S. aureus blood culture. Two subgroups will be individualized depending on the SOFA Score:&#xD;
Severe patients&#xD;
Non-severe patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biological analysis</intervention_name>
    <description>ST types will be determined for all individualized bacterial strains. For all the bacterial strains, RNAs expression will be analyzed at three different growth phases: early exponential phase, mid exponential phase and early stationary phase. Expression of RNAIII and SprD will be evaluated by quantitative polymerase chain reaction.</description>
    <arm_group_label>Colonized patients' group (CPG)</arm_group_label>
    <arm_group_label>SAB patients' group (SAB)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      isolates from patients' blood or nostrils&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients hospitalized S. aureus colonized or with SAB&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years of age;&#xD;
&#xD;
          -  Patients hospitalized at the University Hospital of Rennes, with according to groups:&#xD;
&#xD;
               1. : Colonized subjects:&#xD;
&#xD;
                    -  Any patient hospitalized at the University Hospital of Rennes, or any health&#xD;
                       professional, in whom a colonization screening with S. aureus is performed&#xD;
                       in routine care and a colonization with S. aureus is documented;&#xD;
&#xD;
                  (For information, this screening is carried out frequently at the University&#xD;
                  Hospital of Rennes for different reasons (before surgery or procedure requiring&#xD;
                  the installation of equipment, screening of contact cases of infected cases,&#xD;
                  investigation during a nosocomial epidemic...). These people are hospitalized for&#xD;
                  reasons other than S. aureus infection and in different departments, but the&#xD;
                  samples are collected centrally in the institution's bacteriology laboratory.)&#xD;
&#xD;
               2. : Patients hospitalized for BSA:&#xD;
&#xD;
                    -  Patients hospitalized in the infectious diseases and medical intensive care&#xD;
                       unit and in the surgical intensive care unit, for whom a BSA is documented&#xD;
                       at the bacteriology laboratory of the University Hospital of Rennes;&#xD;
&#xD;
                    -  Patients for whom nasal carrying screening for S. aureus is prescribed as&#xD;
                       part of their management;&#xD;
&#xD;
                    -  These patients will be classified into two groups:&#xD;
&#xD;
                         1. Serious clinic (CG):&#xD;
&#xD;
          -  BSA ;&#xD;
&#xD;
          -  Associated with signs of sepsis according to the 20168 international definition:&#xD;
&#xD;
               -  SOFA score (see Appendix 3) 2 ;&#xD;
&#xD;
               -  Septic shock will be defined as the existence of sepsis associated with&#xD;
                  persistent low blood pressure requiring the administration of vasopressors to&#xD;
                  obtain an average blood pressure (MAP) 65 mmHg and an arterial lactate dosage 2&#xD;
                  mmol/L despite adequate vascular filling.&#xD;
&#xD;
                  2) Non-serious clinic (CNG):&#xD;
&#xD;
          -  BSA ;&#xD;
&#xD;
          -  Which does not meet the definition of the CG group.&#xD;
&#xD;
          -  Having expressed their opposition to this research or whose trusted person does not&#xD;
             oppose the research if the patient is not able to give an informed opinion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women;&#xD;
&#xD;
          -  Persons of full age who are subject to legal protection (protection of justice,&#xD;
             guardianship, guardianship), persons deprived of their liberty;&#xD;
&#xD;
          -  S. aureus strain producing leucocidin from Panton-Valentine;&#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>Matthieu REVEST</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitairede Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Staphylococcus aureus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Staphylococcal Infections</mesh_term>
    <mesh_term>Sepsis</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/NCT03833102
org study id: 35RC17_9726_PROSAC
nct id: NCT03833102
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to demonstrate that the risk of S. aureus bacteremia (SAB) is
      correlated to the RNA III and SprD RNAs expression
Staphylococcus aureus ranks among the top three organisms for community-acquired,
      healthcare-related and nosocomial infections in humans. It lives as a commensal organism but
      can also provoke very severe diseases. Identifying markers of the 'colonization/disease'
      transition is of paramount importance. We recently found that an association of two
      regulatory RNAs was associated with S. aureus infection rather than colonization and with the
      severity of infection. Those preliminary results have to be confirmed with a more important
      prospective cohort.
observational model: Cohort
time perspective: Prospective
measure: Levels of RNAIII expression and sprD in isolated strains of S. aureus from bacteremia
time frame: through study completion, an average of 1 year
description: Levels of expression of RNAIII and sprD in isolated strains of S. aureus isolated from bacteremia, compared to these same levels of expression in strains from colonized, uninfected patients.
arm group label: Colonized patients' group (CPG)
description: all adult patients hospitalized in or consulting the Rennes University Hospital, known as S. aureus colonized could be included. In our institution, S. aureus colonization in the nostrils is screened in all patients supposed to undergo neurosurgical or orthopedic surgery.
arm group label: SAB patients' group (SAB)
description: all adult patients with SAB could be included. S. aureus colonization in the nostrils will be systematically screened immediately after the first result of positive S. aureus blood culture. Two subgroups will be individualized depending on the SOFA Score:
Severe patients
Non-severe patients
intervention type: Other
intervention name: biological analysis
description: ST types will be determined for all individualized bacterial strains. For all the bacterial strains, RNAs expression will be analyzed at three different growth phases: early exponential phase, mid exponential phase and early stationary phase. Expression of RNAIII and SprD will be evaluated by quantitative polymerase chain reaction.
arm group label: Colonized patients' group (CPG)
arm group label: SAB patients' group (SAB)
isolates from patients' blood or nostrils
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthieu REVEST
role: Principal Investigator
affiliation: Centre Hospitalier Universitairede Rennes
facility: 
country: France
responsible party type: Sponsor
mesh term: Staphylococcal Infections
mesh term: Sepsis