<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/NCT01700842</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-IRU-XXX-2012/1</org_study_id>
    <nct_id>NCT01700842</nct_id>
  </id_info>
  <brief_title>Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia</brief_title>
  <acronym>CERBERUS</acronym>
  <official_title>Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <brief_summary>
    <textblock>
      Approximately 3,000 of clinically significant isolates of different species from respective&#xD;
      respective sources in geographically distinct Russian cities will be collected and tested on&#xD;
      ceftaroline and other antimicrobials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Percentage(numerical) MIC distribution of microorganisms for ceftaroline and other tested antimicrobials, including MIC50 and MIC90, percent(quantity)of susceptible and resistant strains in accordance with EUCAST or CLSI recommended breakpoints.</measure>
    <time_frame>up to 3 months</time_frame>
    <description>MIC- Minimum inhibitory concentration; EUCAST - European Committee on Antimicrobial Susceptibility Testing; CLSI- Clinical and Laboratory Standard Institute</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains, to tested antibiotics depend on: infection localization, medical condition, ward/unit profile,patient profile(age)</measure>
    <time_frame>up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains,to ceftaroline and other antimicrobials by years from 2008 to 2012</measure>
    <time_frame>upto 3 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">3000</enrollment>
  <condition>Bacterial Skin Diseases</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Microbiological strains&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        clinical material form patients in geographically distinct Russian cities&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Isolates derived from patients' clinical material will be included in the study&#xD;
&#xD;
          -  Isolates collected retro- and prospectively will be included in the study (from&#xD;
             01.01.2008 till 31.12.2012)&#xD;
&#xD;
          -  Isolates, allocated of a clinical material of adult patients (&gt; 18 years), should make&#xD;
             not less than 70 % from total number of included isolates)&#xD;
&#xD;
          -  All included isolates should be unique: only one isolate can be included in the study&#xD;
             of each biological type from each patient&#xD;
&#xD;
          -  All isolates should correspond to clinic-laboratory criteria of the etiologic&#xD;
             importance, i.e. should be derived from patients with infection symptoms from the&#xD;
             corresponding clinical material&#xD;
&#xD;
          -  Case report form (CRF) (Appendix 1) should be correctly completed for each isolate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum&#xD;
             beta-lactamase)&#xD;
&#xD;
          -  Isolates, arrived in the central laboratory contaminated or unviable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Smolensk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>June 26, 2013</last_update_submitted>
  <last_update_submitted_qc>June 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 27, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ceftaroline, infection, CAPB, CAP, ABSSSI, cSSTI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Diseases, Bacterial</mesh_term>
    <mesh_term>Skin Diseases</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/NCT01700842
org study id: NIS-IRU-XXX-2012/1
nct id: NCT01700842
lead sponsor: 
Approximately 3,000 of clinically significant isolates of different species from respective
      respective sources in geographically distinct Russian cities will be collected and tested on
      ceftaroline and other antimicrobials.
measure: Percentage(numerical) MIC distribution of microorganisms for ceftaroline and other tested antimicrobials, including MIC50 and MIC90, percent(quantity)of susceptible and resistant strains in accordance with EUCAST or CLSI recommended breakpoints.
time frame: up to 3 months
description: MIC- Minimum inhibitory concentration; EUCAST - European Committee on Antimicrobial Susceptibility Testing; CLSI- Clinical and Laboratory Standard Institute
measure: Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains, to tested antibiotics depend on: infection localization, medical condition, ward/unit profile,patient profile(age)
time frame: up to 3 months
measure: Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains,to ceftaroline and other antimicrobials by years from 2008 to 2012
time frame: upto 3 months
Microbiological strains
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Skin Diseases, Bacterial
mesh term: Skin Diseases