<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/NCT01690533</url>
  </required_header>
  <id_info>
    <org_study_id>16515</org_study_id>
    <nct_id>NCT01690533</nct_id>
  </id_info>
  <brief_title>Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease</brief_title>
  <official_title>Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease</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>
      The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg&#xD;
      (hereinafter as &quot;Avelox&quot;) in treating secondary infection of chronic respiratory disease.It&#xD;
      is a local prospective and observational study of patients who have received Avelox tablets&#xD;
      for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in&#xD;
      chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and&#xD;
      assessed during the period of treatment with Avelox.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2008</start_date>
  <completion_date type="Actual">July 19, 2013</completion_date>
  <primary_completion_date type="Actual">December 14, 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>Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)</measure>
    <time_frame>After 7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical efficacy rate (Response, Minor Response, No Response and Indeterminable) assessed by investigator's discretion. Efficacy rate is calculated as number of patients with Response or Minor Response proportional to number of all cases.</measure>
    <time_frame>After 7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ADR incidence rates classified by patient's background factors</measure>
    <time_frame>After 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy rates classified by patient's background factors</measure>
    <time_frame>After 7 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">497</enrollment>
  <condition>Anti-Infective Agents</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avelox (Moxifloxacin, BAY12-8039)</intervention_name>
    <description>Patients treated with Moxifloxacin in daily clinical practice</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with secondary infection of chronic respiratory disease (excluding acute&#xD;
        bronchitis patients who have been determined to be without chronic respiratory tract&#xD;
        disease based on their medical history, x-ray findings, and/or other findings)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with secondary infection of chronic respiratory disease (excluding acute&#xD;
             bronchitis patients who have been determined to be without chronic respiratory tract&#xD;
             disease based on their medical history, x-ray findings, and/or other findings) who&#xD;
             meet the following criteria:&#xD;
&#xD;
          -  20 years old or older&#xD;
&#xD;
          -  with infection of mild or moderate severity&#xD;
&#xD;
          -  Patients who meet the following criteria immediately before starting the therapy:&#xD;
             ≥37°C of body temperature, expectoration of purulent or mucopurulent sputum, and&#xD;
             either white blood cell count ≥8,000/mm3 or CRP ≥0.7 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are contraindicated based on the product label.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>Multiple Locations</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>May 18, 2018</last_update_submitted>
  <last_update_submitted_qc>May 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Avelox</keyword>
  <keyword>Laryngopharyngitis</keyword>
  <keyword>Tonsillitis</keyword>
  <keyword>Bronchitis acute</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Secondary infection in chronic respiratory diseases Sinusitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Coinfection</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
    <mesh_term>Norgestimate, ethinyl estradiol drug combination</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/NCT01690533
org study id: 16515
nct id: NCT01690533
lead sponsor: 
has dmc: No
The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg
      (hereinafter as "Avelox") in treating secondary infection of chronic respiratory disease.It
      is a local prospective and observational study of patients who have received Avelox tablets
      for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in
      chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and
      assessed during the period of treatment with Avelox.
observational model: Case-Only
time perspective: Prospective
measure: Number of adverse drug reactions (ADRs) and serious adverse events (SAEs)
time frame: After 7 days
measure: Clinical efficacy rate (Response, Minor Response, No Response and Indeterminable) assessed by investigator's discretion. Efficacy rate is calculated as number of patients with Response or Minor Response proportional to number of all cases.
time frame: After 7 days
measure: ADR incidence rates classified by patient's background factors
time frame: After 7 days
measure: Efficacy rates classified by patient's background factors
time frame: After 7 days
arm group label: Group 1
intervention type: Drug
intervention name: Avelox (Moxifloxacin, BAY12-8039)
description: Patients treated with Moxifloxacin in daily clinical practice
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Infections
mesh term: Coinfection
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Moxifloxacin
mesh term: Norgestimate, ethinyl estradiol drug combination