<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/NCT01701219</url>
  </required_header>
  <id_info>
    <org_study_id>CPT-MD-32</org_study_id>
    <nct_id>NCT01701219</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia</brief_title>
  <official_title>A Multicenter, 2-Cohort Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Forest Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Forest Laboratories</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus&#xD;
      aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia&#xD;
      persisting after at least 72 hours of vancomycin and/or daptomycin treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with either S. aureus bacteremia or persistent MRSA bacteremia will be treated with&#xD;
      open label ceftaroline fosamil, safety will be monitored and clearance of bacteremia will be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the safety of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment</measure>
    <time_frame>60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days</time_frame>
    <description>Efficacy outcome measures:&#xD;
Time to clearance of bacteremia&#xD;
Time to defervescence&#xD;
Clinical outcome&#xD;
Mortality&#xD;
Readmission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the efficacy of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment</measure>
    <time_frame>Between 3 and 119 days</time_frame>
    <description>Safety evaluations will be conducted and assessments will include:&#xD;
Adverse events including deaths will be evaluated&#xD;
Laboratory: complete blood count (CBC) with differential and chemistry panel</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Staphylococcus Aureus Bacteremia</condition>
  <condition>Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>S. aureus on at least 1 blood culture within 72 hours of beginning study drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>MRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftaroline fosamil</intervention_name>
    <description>Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
    <other_name>Teflaro®</other_name>
    <other_name>PPI-0903</other_name>
    <other_name>TAK-599</other_name>
    <other_name>TAK599</other_name>
    <other_name>PPI0903</other_name>
    <other_name>Zinforo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presence of bacteremia due solely to:&#xD;
&#xD;
               -  S. aureus on at least 1 blood culture within 72 hours of beginning study drug&#xD;
                  (Cohort A) OR&#xD;
&#xD;
               -  MRSA on a baseline blood culture and on at least 1 additional blood culture after&#xD;
                  at least 72 hours of vancomycin and/or daptomycin treatment (Cohort B).&#xD;
&#xD;
          2. Male or female ≥ 18 years of age.&#xD;
&#xD;
          3. If female of childbearing potential must be willing to practice sexual abstinence or&#xD;
             dual methods of contraception during treatment and for at least 30 days after the last&#xD;
             dose of study drug.&#xD;
&#xD;
          4. Expectation of survival for at least 2 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. For subjects in Cohort A: previous therapy for more than 48 hours with any parenteral&#xD;
             antibiotic with activity against S. aureus within 72 hours of positive blood culture&#xD;
             results.&#xD;
&#xD;
          2. For subjects in Cohort B: previous therapy for more than 48 hours with any parenteral&#xD;
             antibiotic with activity against MRSA, except vancomycin and/or daptomycin, within 72&#xD;
             hours of positive blood culture results confirming persistence.&#xD;
&#xD;
          3. Previous episode of S. aureus bacteremia within 3 months.&#xD;
&#xD;
          4. Known left-sided endocarditis or prosthetic heart valve.&#xD;
&#xD;
          5. Osteomyelitis or prosthetic joint infection except new onset nonhardware-associated&#xD;
             vertebral osteomyelitis.&#xD;
&#xD;
          6. History of any hypersensitivity or allergic reaction to any β-lactam antibacterial&#xD;
             agent.&#xD;
&#xD;
          7. Evidence of significant hepatic, hematologic, or immunologic impairment.&#xD;
&#xD;
          8. Pregnant or nursing females.&#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>Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34994</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Laconia</city>
        <state>New Hampshire</state>
        <zip>03246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <zip>11418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Annandale</city>
        <state>Virginia</state>
        <zip>22003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cerexa.com</url>
    <description>Sponsor Website</description>
  </link>
  <verification_date>July 2014</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 5, 2012</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Staphylococcus aureus bacteremia</keyword>
  <keyword>Methicillin-resistant Staphylococcus aureus bacteremia</keyword>
  <keyword>MRSA bacteremia</keyword>
  <keyword>Blood</keyword>
  <keyword>Adult</keyword>
  <keyword>Infections</keyword>
  <keyword>Blood Culture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Staphylococcal Infections</mesh_term>
    <mesh_term>Bacteremia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ceftaroline fosamil</mesh_term>
  </intervention_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/NCT01701219
org study id: CPT-MD-32
nct id: NCT01701219
lead sponsor: 
has dmc: No
This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus
      aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia
      persisting after at least 72 hours of vancomycin and/or daptomycin treatment.
Subjects with either S. aureus bacteremia or persistent MRSA bacteremia will be treated with
      open label ceftaroline fosamil, safety will be monitored and clearance of bacteremia will be
      evaluated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the safety of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment
time frame: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days
description: Efficacy outcome measures:
Time to clearance of bacteremia
Time to defervescence
Clinical outcome
Mortality
Readmission
measure: Evaluate the efficacy of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment
time frame: Between 3 and 119 days
description: Safety evaluations will be conducted and assessments will include:
Adverse events including deaths will be evaluated
Laboratory: complete blood count (CBC) with differential and chemistry panel
arm group label: Cohort A
arm group type: Other
description: S. aureus on at least 1 blood culture within 72 hours of beginning study drug
arm group label: Cohort B
arm group type: Other
description: MRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment
intervention type: Drug
intervention name: Ceftaroline fosamil
description: Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
arm group label: Cohort A
arm group label: Cohort B
other name: Teflaro®
other name: PPI-0903
other name: TAK-599
other name: TAK599
other name: PPI0903
other name: Zinforo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
url: http://www.cerexa.com
description: Sponsor Website
responsible party type: Sponsor
mesh term: Staphylococcal Infections
mesh term: Bacteremia
mesh term: Ceftaroline fosamil