<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/NCT01670435</url>
  </required_header>
  <id_info>
    <org_study_id>15029</org_study_id>
    <secondary_id>CIPRO-IV-2007</secondary_id>
    <nct_id>NCT01670435</nct_id>
  </id_info>
  <brief_title>Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance</brief_title>
  <official_title>Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a post-marketing surveillance in Japan, and it is a local prospective and&#xD;
      observational study of patients who have received Ciproxan intravenously as a first-line&#xD;
      treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical&#xD;
      or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective&#xD;
      of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A&#xD;
      total of 3,000 patients are to be enrolled and assessed during the period of treatment with&#xD;
      Ciproxan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <completion_date type="Actual">October 2010</completion_date>
  <primary_completion_date type="Actual">June 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)</measure>
    <time_frame>After 9 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion</measure>
    <time_frame>After 9 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ADR incidence rates classified by patient's background factors</measure>
    <time_frame>After 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy rate calculated with Response and Minor Response considered as responder</measure>
    <time_frame>After 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy rates classified by patient's background factors</measure>
    <time_frame>After 9 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3274</enrollment>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciprofloxacin (BAYQ3939)</intervention_name>
    <description>Patient treated with Ciproxan as a first line treatment in daily clinical practice</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who received Ciproxan as a first-line treatment were eligible for the study, among&#xD;
        those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia,&#xD;
        peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who received Ciproxan as a first-line treatment were eligible for the study,&#xD;
             among those with sepsis, secondary infection due to trauma, burn, or surgical wound,&#xD;
             pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of&#xD;
             this drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are contraindicated based on the product label.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <name_title>Medical Director</name_title>
    <organization>Bayer Yakuhin, Ltd.</organization>
  </responsible_party>
  <keyword>Ciprofloxacin</keyword>
  <keyword>sepsis</keyword>
  <keyword>infection</keyword>
  <keyword>pneumonia</keyword>
  <keyword>peritonitis</keyword>
  <keyword>cholecystitis</keyword>
  <keyword>cholangitis</keyword>
  <keyword>anthrax</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciprofloxacin</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/NCT01670435
org study id: 15029
secondary id: CIPRO-IV-2007
nct id: NCT01670435
lead sponsor: 
has dmc: No
This study is a post-marketing surveillance in Japan, and it is a local prospective and
      observational study of patients who have received Ciproxan intravenously as a first-line
      treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical
      or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective
      of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A
      total of 3,000 patients are to be enrolled and assessed during the period of treatment with
      Ciproxan.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
time frame: After 9 days
measure: Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
time frame: After 9 days
measure: ADR incidence rates classified by patient's background factors
time frame: After 9 days
measure: Efficacy rate calculated with Response and Minor Response considered as responder
time frame: After 9 days
measure: Efficacy rates classified by patient's background factors
time frame: After 9 days
arm group label: Group 1
intervention type: Drug
intervention name: Ciprofloxacin (BAYQ3939)
description: Patient treated with Ciproxan as a first line treatment in daily clinical practice
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Japan
name title: Medical Director
organization: Bayer Yakuhin, Ltd.
mesh term: Infections
mesh term: Ciprofloxacin