<clinical_study>
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  <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/NCT01669980</url>
  </required_header>
  <id_info>
    <org_study_id>P903-24</org_study_id>
    <nct_id>NCT01669980</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)</brief_title>
  <official_title>A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of safety and effectiveness of ceftaroline fosamil in children with&#xD;
      Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in&#xD;
      pediatric subjects ages 2 months to &lt; 18 years who are initially hospitalized with&#xD;
      Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to&#xD;
      methicillin-resistant Staphylococcus aureus (MRSA)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to &lt; 18 years with complicated community-acquired bacterial pneumonia (CABP)</measure>
    <time_frame>between 1 and 57 days</time_frame>
    <description>Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA).</measure>
    <time_frame>between 4 and 57 days</time_frame>
    <description>Evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)</measure>
    <time_frame>between 4 and 57 days</time_frame>
    <description>Analyze concentrations of ceftaroline, ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) in plasma, and, if available, in cerebrospinal fluid (CSF, if collected as part of standard of care)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Infections</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Ceftaroline fosamil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>IV Ceftriaxone and Vancomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftaroline fosamil</intervention_name>
    <description>Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if &gt; 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)&#xD;
Subjects &lt; 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)&#xD;
Optional Oral Switch:&#xD;
PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h&#xD;
PO clindamycin 13 mg/kg/dose&#xD;
PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h</description>
    <arm_group_label>Ceftaroline fosamil</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>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV Ceftriaxone and Vancomycin</intervention_name>
    <description>IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND&#xD;
IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.&#xD;
Optional Oral Switch:&#xD;
PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h&#xD;
PO clindamycin 13 mg/kg/dose&#xD;
PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h</description>
    <arm_group_label>IV Ceftriaxone and Vancomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of CABP warranting 3 days of initial hospitalization&#xD;
&#xD;
          -  Confirmed presence of indicators of complicated CABP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial&#xD;
&#xD;
          -  Confirmed or suspected infection with a pathogen known to be resistant to IV study&#xD;
             drugs or known infection at baseline with a sole atypical organism&#xD;
&#xD;
          -  Confirmed or suspected respiratory tract infection attributable to sources other than&#xD;
             community acquired bacterial pneumonia&#xD;
&#xD;
          -  Non-infectious causes of pulmonary infiltrates&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Orange County</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 1</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 2</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site 3</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Donetsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kryvyi Rih</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Georgia</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Romania</country>
  </removed_countries>
  <link>
    <url>http://www.cerexa.com</url>
    <description>Sponsor Homepage</description>
  </link>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <disposition_first_submitted>October 5, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>October 5, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 1, 2015</disposition_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infections</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Teflaro</keyword>
  <keyword>Ceftriaxone</keyword>
  <keyword>cephalosporin</keyword>
  <keyword>Vancomycin</keyword>
  <keyword>Clindamycin</keyword>
  <keyword>Amoxicillin Clavulanate</keyword>
  <keyword>Linezolid</keyword>
  <keyword>MRSA</keyword>
  <keyword>pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Ceftriaxone</mesh_term>
    <mesh_term>Ceftaroline fosamil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01669980
org study id: P903-24
nct id: NCT01669980
lead sponsor: 
has dmc: Yes
This is a study of safety and effectiveness of ceftaroline fosamil in children with
      Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in
      pediatric subjects ages 2 months to < 18 years who are initially hospitalized with
      Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to
      methicillin-resistant Staphylococcus aureus (MRSA)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP)
time frame: between 1 and 57 days
description: Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group.
measure: To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA).
time frame: between 4 and 57 days
description: Evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure.
measure: Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
time frame: between 4 and 57 days
description: Analyze concentrations of ceftaroline, ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) in plasma, and, if available, in cerebrospinal fluid (CSF, if collected as part of standard of care)
arm group label: Ceftaroline fosamil
arm group type: Experimental
arm group label: IV Ceftriaxone and Vancomycin
arm group type: Active Comparator
intervention type: Drug
intervention name: Ceftaroline fosamil
description: Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)
Subjects < 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)
Optional Oral Switch:
PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
PO clindamycin 13 mg/kg/dose
PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
arm group label: Ceftaroline fosamil
other name: Teflaro
other name: PPI-0903
other name: TAK-599
other name: TAK599
other name: PPI0903
intervention type: Drug
intervention name: IV Ceftriaxone and Vancomycin
description: IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND
IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.
Optional Oral Switch:
PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
PO clindamycin 13 mg/kg/dose
PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
arm group label: IV Ceftriaxone and Vancomycin
criteria: 
gender: All
minimum age: 2 Months
maximum age: 18 Years
healthy volunteers: No
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country: Argentina
country: Georgia
country: Ukraine
country: United States
country: Romania
url: http://www.cerexa.com
description: Sponsor Homepage
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Vancomycin
mesh term: Ceftriaxone
mesh term: Ceftaroline fosamil