<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/NCT01666743</url>
  </required_header>
  <id_info>
    <org_study_id>CPT-MD-34</org_study_id>
    <nct_id>NCT01666743</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia</brief_title>
  <official_title>A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia</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>
      The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in&#xD;
      elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic&#xD;
      therapy in the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age)&#xD;
      with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A&#xD;
      switch to oral treatment may be allowed at the discretion of the Investigator. The total&#xD;
      duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change in strategy.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">March 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group 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 elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)</measure>
    <time_frame>Between 3 and 33-37 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 with differential, and chemistry panel.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)</measure>
    <time_frame>30 days following discharge from the hospital, anticipated between 33 to 37 days.</time_frame>
    <description>Efficacy outcome measures:&#xD;
Time to clinical stability&#xD;
Length of stay&#xD;
Clinical outcome at End-of-Intravenous Study Drug, End-of-Therapy, and Test-of-Cure&#xD;
Mortality&#xD;
30-day readmission</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Community-Acquired Bacterial Pneumonia (CABP)</condition>
  <arm_group>
    <arm_group_label>Ceftaroline fosamil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftaroline fosamil</intervention_name>
    <description>IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)</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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 65 years of age.&#xD;
&#xD;
          2. Presence of CABP warranting hospitalization.&#xD;
&#xD;
          3. Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract&#xD;
             infection.&#xD;
&#xD;
          4. Radiographically confirmed pneumonia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of any hypersensitivity or allergic reaction to any β-lactam or macrolide&#xD;
             antibacterial agent.&#xD;
&#xD;
          2. Confirmed or suspected respiratory tract infection due solely to an atypical&#xD;
             bacterial, mycobacterial, viral, or fungal pathogen.&#xD;
&#xD;
          3. More than 24 hours of potentially effective antibacterial therapy within 96 hours&#xD;
             prior to enrollment.&#xD;
&#xD;
          4. Life expectancy of &lt; 30 days or presence of an order of Do Not Resuscitate (DNR).&#xD;
&#xD;
          5. Evidence of significant hematologic, hepatic, or immunologic impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.cerexa.com</url>
    <description>Sponsor Website</description>
  </link>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>February 7, 2013</last_update_submitted>
  <last_update_submitted_qc>February 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community-Acquired Pneumonia</keyword>
  <keyword>Lung</keyword>
  <keyword>Adult</keyword>
  <keyword>Infections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Bacterial</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/NCT01666743
org study id: CPT-MD-34
nct id: NCT01666743
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in
      elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic
      therapy in the hospital.
This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age)
      with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A
      switch to oral treatment may be allowed at the discretion of the Investigator. The total
      duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
time frame: Between 3 and 33-37 days
description: Safety evaluations will be conducted and assessments will include:
Adverse events including deaths will be evaluated.
Laboratory: complete blood count with differential, and chemistry panel.
measure: Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
time frame: 30 days following discharge from the hospital, anticipated between 33 to 37 days.
description: Efficacy outcome measures:
Time to clinical stability
Length of stay
Clinical outcome at End-of-Intravenous Study Drug, End-of-Therapy, and Test-of-Cure
Mortality
30-day readmission
arm group label: Ceftaroline fosamil
arm group type: Experimental
description: IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
intervention type: Drug
intervention name: Ceftaroline fosamil
description: IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
arm group label: Ceftaroline fosamil
other name: Teflaro®
other name: PPI-0903
other name: TAK-599
other name: TAK599
other name: PPI0903
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
country: United States
url: http://www.cerexa.com
description: Sponsor Website
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Bacterial
mesh term: Ceftaroline fosamil