<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/NCT01724671</url>
  </required_header>
  <id_info>
    <org_study_id>CPLA 6656</org_study_id>
    <nct_id>NCT01724671</nct_id>
  </id_info>
  <brief_title>Vancomycin Versus Ceftaroline in Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline</brief_title>
  <official_title>A Case Series of Ceftaroline-treated Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline, Compared to Vancomycin-treated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CPL Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Forest Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CPL Associates</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the time to pathogen eradication, and the relationship to the time to clinical&#xD;
      improvement, between ceftaroline and case-matched vancomycin treated controls in the&#xD;
      treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus&#xD;
      aureus (MRSA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial Eradication</measure>
    <time_frame>10 days</time_frame>
    <description>Time to eradication of bacteria from the infection site and/or blood in relation to time to clinical improvement. For Acute Bacterial Skin and Skin Structure Infections (ABSSSI), it is recognized that wound cultures may not be repeated often, so the focus will be on the monitoring of time to clinical resolution in conjunction with time to resolve the bacteremic phase, if bacteremia is present.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test of Cure</measure>
    <time_frame>10 days</time_frame>
    <description>Secondary Efficacy endpoint (Cure, Failure or Indeterminate) will also be assessed at the Test of Cure, 7-10 days after last dose.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>MRSA Infection</condition>
  <condition>Bacteremia</condition>
  <condition>ABSSSI</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Cefatroline</arm_group_label>
    <description>Investigators will retrospectively capture patient cases that have been treated for MRSA with ceftaroline. Cases will only be included if the isolate was tested against vancomycin and ceftaroline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vancomycin</arm_group_label>
    <description>Investigators will retrospectively capture patient cases that were been treated for MRSA with Vancomycin.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      MRSA cultures obtained retrospectively from Microbiology labs if available for patients.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Investigators will retrospectively capture patient cases that have been treated for MRSA&#xD;
        with ceftaroline, either in response to cultures or empirically with subsequent discovery&#xD;
        of MRSA. Cases will only be included if the isolate was tested against vancomycin and&#xD;
        ceftaroline, unless the isolate is available in the microbiology lab to send to the study&#xD;
        coordinating center for subsequent testing of minimum inhibitory concentrations (MIC). Case&#xD;
        matched patients treated with vancomycin will also be collected as the control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A positive MRSA culture, resulting from a blood or properly obtained infection site&#xD;
             sample, with a vancomycin MIC 1.5 - 4.0 mcg/mL and ceftaroline MIC ≤1 mcg/mL.&#xD;
&#xD;
          2. The patient was treated adequately with ceftaroline or vancomycin.&#xD;
&#xD;
          3. A medical history, clinical signs and symptoms, and radiological findings consistent&#xD;
             with infection such as pneumonia, skin and wound, intra-abdominal infection and&#xD;
             bacteremia associated with one of those infection sites.&#xD;
&#xD;
             Patients must have had a body temperature &gt;38C [100.4F] or &lt;36.1C [97F] or&#xD;
             leukocytosis (blood leukocyte count &gt;10,000 cells/mm3) or &gt;10% bands, at baseline. In&#xD;
             the case of pneumonia, chest radiographic examination that show a new or progressive&#xD;
             infiltrate, consolidation, cavitation, or pleural effusion. Rales or dullness to&#xD;
             percussion on physical examination of the chest, new onset of purulent sputum, or&#xD;
             change in quantity or character of sputum. Wound redness, swelling, and/or purulence&#xD;
             in the case of ABSSSI&#xD;
&#xD;
          4. There should be sufficient numbers of follow up cultures of the infection site and/or&#xD;
             blood to determine whether the infecting pathogen was eradicated, and preferably the&#xD;
             day on which the eradication occurred.&#xD;
&#xD;
        Additional inclusion criteria for patients with pneumonia:&#xD;
&#xD;
          1. Suspected or confirmed acute bacterial pneumonia due to MRSA in one of the following&#xD;
             subgroups:&#xD;
&#xD;
             Community-acquired bacterial pneumonia (CABP) i.e. those cases acquired outside the&#xD;
             hospital and being admitted to the hospital for treatment of their pneumonia;&#xD;
&#xD;
             or&#xD;
&#xD;
             Hospital-acquired bacterial pneumonia (HABP), i.e., pneumonia that occurs 72 hours or&#xD;
             more after admission, which was not incubating at the time of admission;&#xD;
&#xD;
             or&#xD;
&#xD;
             Ventilator-associated bacterial pneumonia (VABP), i.e., pneumonia that arises more&#xD;
             than 48 hours after endotracheal intubation and ventilation;&#xD;
&#xD;
             or&#xD;
&#xD;
             Health Care-associated bacterial pneumonia (HCABP), which includes patients admitted&#xD;
             from a long term care facility.&#xD;
&#xD;
          2. Pulmonary infiltration consistent with the diagnosis of pneumonia (new or progressive&#xD;
             infiltrates, consolidation, with or without the presence of pleural effusion)&#xD;
             documented by chest X-ray or CT within 48 hours prior to enrollment.&#xD;
&#xD;
          3. Suitable respiratory specimen (sputum/endotracheal specimen or specimen from an&#xD;
             invasive procedure) for culture and Gram stain, with Gram-positive pathogens as the&#xD;
             predominant organism. Average of at least 10 Gram-positive organisms per oil-immersion&#xD;
             field in 10 fields (actual or calculated, 100x objective).&#xD;
&#xD;
        Additional inclusion criteria for patients with other infection sites:&#xD;
&#xD;
          1. In all cases of bacteremia linked to a site/source, the isolate species and&#xD;
             susceptibility should match between blood and primary site. Typical non-pneumonia&#xD;
             sites of infection will include complicated intra-abdominal (cIAI) and ABSSSI.&#xD;
&#xD;
          2. In contrast, bacteremic patients with IV catheter as the only source will require that&#xD;
             the catheter was removed/replaced, and yet the patient remains culture positive for at&#xD;
             least 24 hr after replacement of the catheter.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Age &lt;18 years&#xD;
&#xD;
          2. Pregnant or lactating women&#xD;
&#xD;
          3. Life expectancy &lt;3 months from underlying disease&#xD;
&#xD;
          4. Infection with Mycobacterium tuberculosis&#xD;
&#xD;
          5. Organism is not available or is not tested locally for MIC to ceftaroline or&#xD;
             vancomycin&#xD;
&#xD;
          6. Bacteremia determined to be catheter-related with no definitive evidence of a&#xD;
             secondary source&#xD;
&#xD;
          7. Patient is on a prior antibiotic and shows clinical improvement or negative cultures&#xD;
             before treatment of ceftaroline (or vancomycin for control patients).&#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>Jerome J Schentag, Pharm.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>State University at Buffalo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jerome J Schentag, Pharm.D</last_name>
    <phone>716-633-3330</phone>
    <phone_ext>204</phone_ext>
    <email>jschentag@cplassociates.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joseph Paladino, Pharm.D.</last_name>
    <phone>716-633-3330</phone>
    <phone_ext>202</phone_ext>
    <email>jpaladino@cplassociates.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Erie County Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Joseph Paladino, Pharm.D.</last_name>
      <phone>716-633-3330</phone>
      <phone_ext>202</phone_ext>
      <email>jpaladino@cplassociates.com</email>
    </contact>
    <investigator>
      <last_name>Joseph Paladino, Pharm.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CPL Associates</investigator_affiliation>
    <investigator_full_name>Jerome Schentag</investigator_full_name>
    <investigator_title>Pharm.D.</investigator_title>
  </responsible_party>
  <keyword>MRSA</keyword>
  <keyword>Bacteremia</keyword>
  <keyword>ABSSSI</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Vancomycin</keyword>
  <keyword>Ceftaroline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Bacteremia</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/NCT01724671
org study id: CPLA 6656
nct id: NCT01724671
lead sponsor: 
collaborator: 
has dmc: No
To compare the time to pathogen eradication, and the relationship to the time to clinical
      improvement, between ceftaroline and case-matched vancomycin treated controls in the
      treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus
      aureus (MRSA).
observational model: Case-Control
time perspective: Retrospective
measure: Bacterial Eradication
time frame: 10 days
description: Time to eradication of bacteria from the infection site and/or blood in relation to time to clinical improvement. For Acute Bacterial Skin and Skin Structure Infections (ABSSSI), it is recognized that wound cultures may not be repeated often, so the focus will be on the monitoring of time to clinical resolution in conjunction with time to resolve the bacteremic phase, if bacteremia is present.
measure: Test of Cure
time frame: 10 days
description: Secondary Efficacy endpoint (Cure, Failure or Indeterminate) will also be assessed at the Test of Cure, 7-10 days after last dose.
arm group label: Cefatroline
description: Investigators will retrospectively capture patient cases that have been treated for MRSA with ceftaroline. Cases will only be included if the isolate was tested against vancomycin and ceftaroline
arm group label: Vancomycin
description: Investigators will retrospectively capture patient cases that were been treated for MRSA with Vancomycin.
MRSA cultures obtained retrospectively from Microbiology labs if available for patients.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jerome J Schentag, Pharm.D.
role: Principal Investigator
affiliation: State University at Buffalo
last name: Jerome J Schentag, Pharm.D
phone: 716-633-3330
phone ext: 204
email: jschentag@cplassociates.com
last name: Joseph Paladino, Pharm.D.
phone: 716-633-3330
phone ext: 202
email: jpaladino@cplassociates.com
facility: 
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: CPL Associates
investigator full name: Jerome Schentag
investigator title: Pharm.D.
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pneumonia
mesh term: Bacteremia