<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/NCT01721408</url>
  </required_header>
  <id_info>
    <org_study_id>B1811185</org_study_id>
    <nct_id>NCT01721408</nct_id>
  </id_info>
  <brief_title>A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection</brief_title>
  <official_title>A Multicenter, Double-blind, Randomized, Comparison Study Of The Efficacy And Safety Of Tigecycline To Imipenem/Cilastatin To Treat Complicated Intra-abdominal Infections In Hospitalized Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin&#xD;
      in hospitalized patients with a complicated intra-abdominal infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population</measure>
    <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
    <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population</measure>
    <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
    <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population</measure>
    <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
    <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological Response at the Subject Level in the ME Population at the TOC Assessment</measure>
    <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
    <description>The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness</measure>
    <time_frame>From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)</time_frame>
    <description>An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">470</enrollment>
  <condition>Intra-abdominal Infection</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tigecycline</intervention_name>
    <description>every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipenem/cilastatin</intervention_name>
    <description>every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized male or female subjects, at least 18 year of age.&#xD;
&#xD;
          -  Complicated intra-abdominal infection is present at most under two weeks duration.&#xD;
&#xD;
          -  Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly&#xD;
             suspected intra-abdominal infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticipated length of antibiotic therapy less than 5 days or the likelihood that the&#xD;
             subject will not complete the course of treatment.&#xD;
&#xD;
          -  Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not&#xD;
             susceptible to both of the study drugs.&#xD;
&#xD;
          -  Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment&#xD;
             except for subjects declared prior failures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</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>
  <location>
    <facility>
      <name>Anqing City Hospital</name>
      <address>
        <city>Anqing</city>
        <state>Anhui</state>
        <zip>246003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Hepatobiliary Surgery, Peking University People's Hospital</name>
      <address>
        <city>Xicheng District</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhangzhou Municipal Hospital of Fujian Province</name>
      <address>
        <city>Zhangzhou</city>
        <state>Fujian</state>
        <zip>363000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of JiNan University/General Surgery</name>
      <address>
        <city>GuangZhou</city>
        <state>Guangdong</state>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Shantou University School of Medicine</name>
      <address>
        <city>Shantou</city>
        <state>Guangdong</state>
        <zip>515041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Second People's Hosptial/Department of hepatobiliary surgery</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518039</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Guilin Medical University</name>
      <address>
        <city>Guilin</city>
        <state>Guangxi</state>
        <zip>541001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HaiKou Municipal People's Hospital</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570208</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan Provincial People's Hospital</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570311</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third People's Hospital of Hainan Province/department of general surgery</name>
      <address>
        <city>Sanya</city>
        <state>Hainan</state>
        <zip>572000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University/Intensive Care Unit</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central-South University/General Surgery</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University/Department of General Surgery</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Hospital of Changsha/Department of Surgery</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baotou Central Hospital</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <zip>014000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department</name>
      <address>
        <city>Jiangyin</city>
        <state>Jiangsu</state>
        <zip>214400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yangzhou No.1 People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Province People's Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University/Surgery</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qinghai Provincial People's Hospital</name>
      <address>
        <city>Xining</city>
        <state>Qinghai</state>
        <zip>810007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Binzhou Medical University Hospital</name>
      <address>
        <city>Bin Zhou</city>
        <state>Shandong</state>
        <zip>256603</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Fengxian District Central Hospital, Department of Surgery</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of General Surgery, Sichuan Provincial People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Chengdu Military Region of PLA</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First people's Hospital of Kunming</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of College of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province</name>
      <address>
        <city>Linhai</city>
        <state>Zhejiang</state>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lishui People's Hospital/Intensive Care Unit</name>
      <address>
        <city>Lishui</city>
        <state>Zhejiang</state>
        <zip>323000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Meitan General Hospital/General Surgery Department</name>
      <address>
        <city>Beijing</city>
        <zip>100028</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Navy General Hospital PLA China/Genaral Surgery Department</name>
      <address>
        <city>Beijing</city>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of General Surgery, Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Antibiotics, Hua Shan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery,</name>
      <address>
        <city>Shanghai</city>
        <zip>201700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Union Medical Center</name>
      <address>
        <city>Tianjin</city>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of General Surgery, Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Nankai Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1811185&amp;StudyName=A%20Study%20To%20Determine%20The%20Efficacy%20And%20Safety%20Of%20Tigecycline%20Compared%20With%20Imipenem/Cliastatin%20to%20Treat%20Complicated%20Intra-Abdominal%20Infection</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>September 29, 2016</results_first_submitted>
  <results_first_submitted_qc>September 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 9, 2018</results_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Intraabdominal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imipenem</mesh_term>
    <mesh_term>Tigecycline</mesh_term>
    <mesh_term>Cilastatin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the total of 470 participants randomized, 235 were randomized to each treatment group. Seven participants (4 in tigecycline group and 3 in imipenem/cilastatin group) did not receive study treatment. One participant was randomized to imipenem/cilastatin group but received tigecycline and was reported and analyzed under the tigecycline group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tigecycline 50mg</title>
          <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
        </group>
        <group group_id="P2">
          <title>Imipenem/Cilastatin</title>
          <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="232">Number of participants treated.</participants>
                <participants group_id="P2" count="231">Number of participants treated.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="196"/>
                <participants group_id="P2" count="207"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insufficient clinical response</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer willing to participate study</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Does not meet entrance criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tigecycline 50mg</title>
          <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
        </group>
        <group group_id="B2">
          <title>Imipenem/Cilastatin</title>
          <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="232"/>
            <count group_id="B2" value="231"/>
            <count group_id="B3" value="463"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.4" spread="18.1"/>
                    <measurement group_id="B2" value="48.2" spread="17.6"/>
                    <measurement group_id="B3" value="48.3" spread="17.8"/>
                  </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="83"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population</title>
        <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
        <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
        <population>The CE population was defined as all clinical modified intent-to-treat (c-mITT) participants who satisfied clinical evaluability criteria and had no major protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>Tigecycline 50mg</title>
            <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
          </group>
          <group group_id="O2">
            <title>Imipenem/Cilastatin</title>
            <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population</title>
          <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
          <population>The CE population was defined as all clinical modified intent-to-treat (c-mITT) participants who satisfied clinical evaluability criteria and had no major protocol violations.</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="207"/>
                <count group_id="O2" value="205"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.9" lower_limit="84.9" upper_limit="93.6"/>
                    <measurement group_id="O2" value="96.6" lower_limit="93.1" upper_limit="98.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="6.4" upper_limit="15.1"/>
                    <measurement group_id="O2" value="3.4" lower_limit="1.4" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assuming that the 2 treatments were equally effective, with cure rates of 75 % at the TOC assessment, the study was powered to ensure with 90% probability that the lower limit of a 2-sided 95% confidence interval (CI) for the true difference (tigecycline minus imipenem/cilastatin) in cure rates was greater than -15%.</non_inferiority_desc>
            <p_value>0.0008</p_value>
            <method>See method of CI</method>
            <param_type>Difference in percentage</param_type>
            <param_value>-6.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.0</ci_lower_limit>
            <ci_upper_limit>-1.4</ci_upper_limit>
            <estimate_desc>Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population</title>
        <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
        <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
        <population>The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Tigecycline 50mg</title>
            <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
          </group>
          <group group_id="O2">
            <title>Imipenem/Cilastatin</title>
            <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population</title>
          <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
          <population>The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria.</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="125"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.0" lower_limit="81.0" upper_limit="93.1"/>
                    <measurement group_id="O2" value="95.3" lower_limit="89.4" upper_limit="98.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="6.9" upper_limit="19.0"/>
                    <measurement group_id="O2" value="4.7" lower_limit="1.5" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.</non_inferiority_desc>
            <p_value>0.0277</p_value>
            <method>See method of CI</method>
            <param_type>Difference in percentage</param_type>
            <param_value>-7.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.2</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>CIs and p-values for between-group treatment difference in cure rate were calculated by the asymptotic method corrected for continuity with normal distribution approximation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Microbiological Response at the Subject Level in the ME Population at the TOC Assessment</title>
        <description>The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.</description>
        <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
        <population>The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria. n=number of participants with each microbiological response.</population>
        <group_list>
          <group group_id="O1">
            <title>Tigecycline 50mg</title>
            <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
          </group>
          <group group_id="O2">
            <title>Imipenem/Cilastatin</title>
            <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</description>
          </group>
        </group_list>
        <measure>
          <title>Microbiological Response at the Subject Level in the ME Population at the TOC Assessment</title>
          <description>The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.</description>
          <population>The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria. n=number of participants with each microbiological response.</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="125"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eradication (N=125, 107)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.0" lower_limit="81.0" upper_limit="93.1"/>
                    <measurement group_id="O2" value="95.3" lower_limit="89.4" upper_limit="98.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Eradication (N=110, 102)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="0.6" upper_limit="7.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presumed Eradication (N=110, 102)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="92.2" upper_limit="99.4"/>
                    <measurement group_id="O2" value="100.0" lower_limit="96.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistence (N=125, 107)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="5.7" upper_limit="17.1"/>
                    <measurement group_id="O2" value="4.7" lower_limit="1.5" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Persistence (N=13, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="0.5" upper_limit="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presumed Persistence (N=13, 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" lower_limit="64.0" upper_limit="99.8"/>
                    <measurement group_id="O2" value="80.0" lower_limit="28.4" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superinfection (N=125, 107)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="0.2" upper_limit="5.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in eradication rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.</non_inferiority_desc>
            <p_value>0.0277</p_value>
            <method>See method of CI</method>
            <param_type>Difference in percentage</param_type>
            <param_value>-7.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.2</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
            <estimate_desc>CIs and p-values for between-group treatment difference in eradication rates were calculated by the asymptotic method corrected for continuity with normal distribution approximation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness</title>
        <description>An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.</description>
        <time_frame>From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)</time_frame>
        <population>Safety population included all participants who received at least 1 dose of investigational product. There was 1 participant (who was included in the safety population) had 7 AEs including 1 SAE which were identified after database release and were not reflected in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>Tigecycline 50mg</title>
            <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
          </group>
          <group group_id="O2">
            <title>Imipenem/Cilastatin</title>
            <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness</title>
          <description>An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.</description>
          <population>Safety population included all participants who received at least 1 dose of investigational product. There was 1 participant (who was included in the safety population) had 7 AEs including 1 SAE which were identified after database release and were not reflected in the table.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="232"/>
                <count group_id="O2" value="231"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number (#) of Participants with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of Participants with Treatment-Related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of Participants with SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of Participants with Treatment-Related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population</title>
        <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
        <time_frame>Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)</time_frame>
        <population>The MITT population was defined as all randomized participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tigecycline 50mg</title>
            <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
          </group>
          <group group_id="O2">
            <title>Imipenem/Cilastatin</title>
            <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population</title>
          <description>The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).</description>
          <population>The MITT population was defined as all randomized participants who received at least 1 dose of investigational product.</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="232"/>
                <count group_id="O2" value="231"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.8" lower_limit="77.3" upper_limit="87.4"/>
                    <measurement group_id="O2" value="88.7" lower_limit="83.9" upper_limit="92.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="6.7" upper_limit="15.0"/>
                    <measurement group_id="O2" value="3.5" lower_limit="1.5" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="4.0" upper_limit="11.0"/>
                    <measurement group_id="O2" value="7.8" lower_limit="4.7" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.</non_inferiority_desc>
            <p_value>0.0040</p_value>
            <method>See method of CI</method>
            <param_type>Difference in percentage</param_type>
            <param_value>-6.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.8</ci_lower_limit>
            <ci_upper_limit>0.8</ci_upper_limit>
            <estimate_desc>Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first dose of study treatment (for non-serious AEs)/the time that the subject provided informed consent (for SAEs) through post therapy follow-up (28 days after the last dose of therapy)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tigecycline 50mg</title>
          <description>Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline.</description>
        </group>
        <group group_id="E2">
          <title>Imipenem/Cilastatin</title>
          <description>Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin.</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="32" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drug ineffective</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Postoperative fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="57" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="232"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="232"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="232"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="232"/>
              </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/NCT01721408
org study id: B1811185
nct id: NCT01721408
lead sponsor: 
has dmc: Yes
This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin
      in hospitalized patients with a complicated intra-abdominal infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population
time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
description: The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
measure: Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population
time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
description: The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
measure: Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population
time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
description: The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).
measure: Microbiological Response at the Subject Level in the ME Population at the TOC Assessment
time frame: Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)
description: The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness
time frame: From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)
description: An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
arm group label: Group A
arm group type: Experimental
arm group label: Group B
arm group type: Active Comparator
intervention type: Drug
intervention name: Tigecycline
description: every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.
arm group label: Group A
intervention type: Drug
intervention name: Imipenem/cilastatin
description: every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1811185&StudyName=A%20Study%20To%20Determine%20The%20Efficacy%20And%20Safety%20Of%20Tigecycline%20Compared%20With%20Imipenem/Cliastatin%20to%20Treat%20Complicated%20Intra-Abdominal%20Infection
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Intraabdominal Infections
mesh term: Imipenem
mesh term: Tigecycline
mesh term: Cilastatin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 