<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/NCT01671280</url>
  </required_header>
  <id_info>
    <org_study_id>A0661207</org_study_id>
    <nct_id>NCT01671280</nct_id>
  </id_info>
  <brief_title>Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)</brief_title>
  <acronym>RESCUE</acronym>
  <official_title>Drug Use Investigation Of Azithromycin Iv</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To collect the efficacy and safety information of Azithromycin IV related to their&#xD;
      appropriate use in daily practice&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2012</start_date>
  <completion_date type="Actual">April 22, 2016</completion_date>
  <primary_completion_date type="Actual">April 22, 2016</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 Participants With Treatment-Related Adverse Events</measure>
    <time_frame>29 days</time_frame>
    <description>A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Effectiveness Rate in Participants With Pneumonia</measure>
    <time_frame>29 days</time_frame>
    <description>Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease</measure>
    <time_frame>29 days</time_frame>
    <description>Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">403</enrollment>
  <condition>Pneumonia</condition>
  <condition>Pelvic Inflammatory Disease</condition>
  <arm_group>
    <arm_group_label>Azithromycin IV</arm_group_label>
    <description>Subjects who are treated with Azithromycin IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin IV</intervention_name>
    <description>The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.&#xD;
The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.</description>
    <arm_group_label>Azithromycin IV</arm_group_label>
    <other_name>Zithromac IV</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients whom an investigator involviong A0661207 prescribes the Zithromac IV.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female patients who are prescribed Zithromac IV for pneumonia or pelvic&#xD;
             inflammatory disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have been prescribed Zithromac IV for pneumonia or pelvic inflammatory&#xD;
             disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661207&amp;StudyName=Drug%20Use%20Investigation%20Of%20Azithromycin%20IV%20For%20Community-Acquired%20Pneumonia%20Or%20Pelvic%20Inflammatory%20Disease%20%28Regulatory%20Post%20Marketing%20Commitm</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>March 15, 2017</results_first_submitted>
  <results_first_submitted_qc>March 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2017</results_first_posted>
  <last_update_submitted>March 15, 2017</last_update_submitted>
  <last_update_submitted_qc>March 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pneumonia</keyword>
  <keyword>pelvic inflammatory disease</keyword>
  <keyword>Zithromax</keyword>
  <keyword>Zithromac</keyword>
  <keyword>Japanese</keyword>
  <keyword>Regulatory Post Marketing Commitment Plan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pelvic Inflammatory Disease</mesh_term>
    <mesh_term>Pelvic Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zithromac Intravenous Use (Azithromycin Hydrate)</title>
          <description>Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="403">The number is enrollment.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="401"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 401 participants completed this study. Of the 401 participants, 1 participant was excluded from the baseline analysis due to protocol violation.</population>
      <group_list>
        <group group_id="B1">
          <title>Zithromac Intravenous Use (Azithromycin Hydrate)</title>
          <description>Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="400"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;15 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥15 and &lt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="206"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease Type</title>
          <description>* indicates comorbidities tabulated in duplicate.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Pneumonia*</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pelvic inflammatory disease*</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other*</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Related Adverse Events</title>
        <description>A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.</description>
        <time_frame>29 days</time_frame>
        <population>The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.</population>
        <group_list>
          <group group_id="O1">
            <title>Zithromac Intravenous Use (Azithromycin Hydrate)</title>
            <description>Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Related Adverse Events</title>
          <description>A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.</description>
          <population>The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment-Related Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Related Serious Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Effectiveness Rate in Participants With Pneumonia</title>
        <description>Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.</description>
        <time_frame>29 days</time_frame>
        <population>The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of pneumonia (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as &quot;unassessable&quot; were excluded from the calculation.</population>
        <group_list>
          <group group_id="O1">
            <title>Zithromac Intravenous Use (Azithromycin Hydrate)</title>
            <description>Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Effectiveness Rate in Participants With Pneumonia</title>
          <description>Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.</description>
          <population>The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of pneumonia (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as &quot;unassessable&quot; were excluded from the calculation.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.6" lower_limit="85.20" upper_limit="93.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease</title>
        <description>Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.</description>
        <time_frame>29 days</time_frame>
        <population>The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of PID (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as &quot;unassessable&quot; were excluded from the calculation.</population>
        <group_list>
          <group group_id="O1">
            <title>Zithromac Intravenous Use (Azithromycin Hydrate)</title>
            <description>Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease</title>
          <description>Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.</description>
          <population>The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of PID (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as &quot;unassessable&quot; were excluded from the calculation.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2" lower_limit="83.41" upper_limit="96.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Zithromac Intravenous Use (Azithromycin Hydrate)</title>
          <description>Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Gastritis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Gastroenteritis staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Idiopathic pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1.0</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01671280
org study id: A0661207
nct id: NCT01671280
lead sponsor: 
has dmc: No
To collect the efficacy and safety information of Azithromycin IV related to their
      appropriate use in daily practice
observational model: Case-Only
time perspective: Prospective
measure: Number of Participants With Treatment-Related Adverse Events
time frame: 29 days
description: A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.
measure: Clinical Effectiveness Rate in Participants With Pneumonia
time frame: 29 days
description: Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.
measure: Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease
time frame: 29 days
description: Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.
arm group label: Azithromycin IV
description: Subjects who are treated with Azithromycin IV
intervention type: Drug
intervention name: Azithromycin IV
description: The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.
The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.
arm group label: Azithromycin IV
other name: Zithromac IV
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661207&StudyName=Drug%20Use%20Investigation%20Of%20Azithromycin%20IV%20For%20Community-Acquired%20Pneumonia%20Or%20Pelvic%20Inflammatory%20Disease%20%28Regulatory%20Post%20Marketing%20Commitm
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pelvic Inflammatory Disease
mesh term: Pelvic Infection
mesh term: Azithromycin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 