<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/NCT03293485</url>
  </required_header>
  <id_info>
    <org_study_id>7655A-017</org_study_id>
    <secondary_id>173738</secondary_id>
    <nct_id>NCT03293485</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) in Japanese Participants With Complicated Intra-abdominal Infection or Complicated Urinary Tract Infection (MK-7655A-017)</brief_title>
  <official_title>A Phase III Non-randomized, Non-controlled, Open Label Clinical Trial to Study the Safety and Efficacy of Imipenem/Cilastatin/Relebactam (IMI/REL [MK-7655A]) in Japanese Subjects With Complicated Intra-Abdominal Infection (cIAI) or Complicated Urinary Tract Infection (cUTI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL,&#xD;
      MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or&#xD;
      complicated urinary tract infection (cUTI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">September 14, 2018</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing ≥1 Adverse Events (AE)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)</measure>
    <time_frame>Up to 14 days (End of Therapy Visit)</time_frame>
    <description>The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit</measure>
    <time_frame>Between Day 5 and Day 14 (End of Therapy Visit)</time_frame>
    <description>The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of &quot;cure&quot; or &quot;improved&quot; as determined by the investigator at the End of Therapy Visit. &quot;Cure&quot; is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. &quot;Improved&quot; is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit</measure>
    <time_frame>Between Day 5 and Day 14 (End of Therapy Visit)</time_frame>
    <description>The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to &lt;10^4 CFU/mL) of all uropathogens found at study entry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit</measure>
    <time_frame>Between Day 10 and Day 23 (Test of Cure Visit)</time_frame>
    <description>The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of &quot;cure&quot; as determined by the investigator at the Test of Cure Visit. &quot;Cure&quot; is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to &quot;preinfection status&quot;) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit</measure>
    <time_frame>Between Day 10 and Day 23 (Test of Cure Visit)</time_frame>
    <description>The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to &lt;10^4 CFU/mL) of all uropathogens found at study entry.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Complicated Intra-abdominal Infection</condition>
  <condition>Complicated Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>Imipenem+Cilastatin/Relebactam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with cIAI or cUTI will receive imipenem+cilastatin/relebactam intravenous (IV) infusion once every 6 hours for 5 to 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipenem+Cilastatin/Relebactam</intervention_name>
    <description>Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours</description>
    <arm_group_label>Imipenem+Cilastatin/Relebactam</arm_group_label>
    <other_name>IMI/REL</other_name>
    <other_name>MK-7655A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  requires hospitalization and treatment with IV antibiotic therapy for complicated&#xD;
             intraabdominal infection (cIAI) or complicated urinary tract infection (cUTI).&#xD;
             Per-protocol diagnostic criteria apply to the qualifying infection types.&#xD;
&#xD;
          -  infection is known or thought to be caused by microorganisms susceptible to the IV&#xD;
             study therapy&#xD;
&#xD;
          -  baseline specimen for primary infection site culture obtained at operative procedure&#xD;
             in Screening period or at Baseline for cIAI participants, and within 48 hours before&#xD;
             initiation of IV study drug for cUTI participants&#xD;
&#xD;
          -  female or male who is not of reproductive potential, or female or male who is of&#xD;
             reproductive potential and agrees to avoid becoming pregnant or impregnating a partner&#xD;
             from the time of consent through completion of the study, by practicing abstinence&#xD;
             from heterosexual activity or using acceptable contraception during heterosexual&#xD;
             activity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  received any amount of effective antibiotic therapy after obtaining the culture for&#xD;
             admission to the study and before administration of the first dose of IV study therapy&#xD;
&#xD;
          -  received treatment with systemic effective antibiotics for &gt;24 hours within the 72&#xD;
             hours before initiation of study therapy&#xD;
&#xD;
          -  has a concurrent infection, including endocarditis, osteomyelitis, meningitis, or&#xD;
             prosthetic joint infection, that would interfere with evaluation of response to&#xD;
             IMI/REL&#xD;
&#xD;
          -  has a cIAI or cUTI due to a confirmed fungal pathogen&#xD;
&#xD;
          -  has a cUTI that meets any of the following: 1) complete obstruction of any portion of&#xD;
             the urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4)&#xD;
             presence of indwelling urinary catheter which cannot be removed at study entry&#xD;
&#xD;
          -  has a cIAI that meets any of the following: 1) infection that should be managed by&#xD;
             Staged Abdominal Repair (STAR) or open abdomen therapy, 2) infection limited to the&#xD;
             hollow viscus&#xD;
&#xD;
          -  history of serious allergy, hypersensitivity, or any serious reaction to any&#xD;
             carbapenem, cephalosporin, penicillin or other beta-lactam agent, or other&#xD;
             beta-lactamase inhibitors&#xD;
&#xD;
          -  female who is pregnant or is expecting to conceive, is breastfeeding, or plans to&#xD;
             breastfeed before completion of the study&#xD;
&#xD;
          -  history of a seizure disorder&#xD;
&#xD;
          -  anticipates to be treated with valproic acid, concomitant IV or an oral antimicrobial&#xD;
             considered effective to the index pathogen, in addition to the study treatment&#xD;
&#xD;
          -  is receiving immunosuppressive therapy, including high-dose corticosteroids&#xD;
&#xD;
          -  is undergoing hemodialysis or peritoneal dialysis&#xD;
&#xD;
          -  participated in any other clinical study involving an investigational or experimental&#xD;
             medication during the previous 30 days before Screening.&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nagoya Ekisaikai Hospital ( Site 1724)</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>454-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toyota Memorial Hospital ( Site 1708)</name>
      <address>
        <city>Toyota</city>
        <state>Aichi</state>
        <zip>471-8513</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Chiyukai Fukuoka Shin Mizumaki Hospital ( Site 1710)</name>
      <address>
        <city>Onga-gun</city>
        <state>Fukuoka</state>
        <zip>807-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shin Yukuhashi Hospital ( Site 1722)</name>
      <address>
        <city>Yukuhashi</city>
        <state>Fukuoka</state>
        <zip>824-0026</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Fukuyama Medical Center ( Site 1706)</name>
      <address>
        <city>Fukuyama</city>
        <state>Hiroshima</state>
        <zip>720-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuyama City Hospital ( Site 1721)</name>
      <address>
        <city>Fukuyama</city>
        <state>Hiroshima</state>
        <zip>721-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KKR Sapporo Medical Center ( Site 1728)</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>062-0931</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sano Hospital ( Site 1701)</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>655-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Mito Medical Center ( Site 1729)</name>
      <address>
        <city>Higashiibaraki-gun</city>
        <state>Ibaraki</state>
        <zip>311-3193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Tokushukai Koga General Hospital ( Site 1712)</name>
      <address>
        <city>Koga</city>
        <state>Ibaraki</state>
        <zip>306-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishikawa Prefectural Central Hospital ( Site 1707)</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kanazawa Medical Center ( Site 1716)</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawahara Clinic ( Site 1719)</name>
      <address>
        <city>Aira</city>
        <state>Kagoshima</state>
        <zip>899-5431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Yokohama Medical Center ( Site 1702)</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>245-8575</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Mie Chuo Medical Center ( Site 1727)</name>
      <address>
        <city>Tsu</city>
        <state>Mie</state>
        <zip>514-1101</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japan Labour Health And Safety Organization Tohoku Rosai Hospital ( Site 1714)</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>981-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Sendai Medical Center ( Site 1723)</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>983-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suwa Red Cross Hospital ( Site 1705)</name>
      <address>
        <city>Suwa</city>
        <state>Nagano</state>
        <zip>392-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Nagasaki Medical Center ( Site 1718)</name>
      <address>
        <city>Omura</city>
        <state>Nagasaki</state>
        <zip>856-8562</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Osaka Minami Medical Center ( Site 1715)</name>
      <address>
        <city>Kawachinagano</city>
        <state>Osaka</state>
        <zip>586-8521</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Utsunomiya National Hospital ( Site 1711)</name>
      <address>
        <city>Utsunomiya</city>
        <state>Tochigi</state>
        <zip>329-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Minami Wakayama Medical Center ( Site 1725)</name>
      <address>
        <city>Tanabe</city>
        <state>Wakayama</state>
        <zip>646-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamanashi Prefectural Central Hospital ( Site 1703)</name>
      <address>
        <city>Kofu</city>
        <state>Yamanashi</state>
        <zip>400-8506</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuiken Saiseikai Hospital ( Site 1704)</name>
      <address>
        <city>Fukui</city>
        <zip>918-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Chiyukai Fukuoka Wajiro Hospital ( Site 1709)</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-0213</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Shingenkai Kawahara Urological Clinic ( Site 1726)</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Seifukai Yagi Clinic ( Site 1720)</name>
      <address>
        <city>Kagoshima</city>
        <zip>891-0105</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kumamoto Medical Center ( Site 1713)</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Oita Medical Center ( Site 1717)</name>
      <address>
        <city>Oita</city>
        <zip>870-0263</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <results_reference>
    <citation>Kohno S, Bando H, Yoneyama F, Kikukawa H, Kawahara K, Shirakawa M, Aoyama N, Brown M, Paschke A, Takase A. The safety and efficacy of relebactam/imipenem/cilastatin in Japanese patients with complicated intra-abdominal infection or complicated urinary tract infection: A multicenter, open-label, noncomparative phase 3 study. J Infect Chemother. 2021 Feb;27(2):262-270. doi: 10.1016/j.jiac.2020.09.032. Epub 2020 Nov 13.</citation>
    <PMID>33191112</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>August 23, 2019</results_first_submitted>
  <results_first_submitted_qc>August 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2019</results_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</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>Urinary Tract Infections</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>Relebactam</mesh_term>
    <mesh_term>Cilastatin, Imipenem Drug Combination</mesh_term>
    <mesh_term>Cilastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03293485/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>cIAI/cUTI</title>
          <description>Participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI) received intravenous imipenem+cilastatin+relebactam (IMI/REL) once every 6 hours for 5-14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <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>
      <group_list>
        <group group_id="B1">
          <title>cIAI/cUTI</title>
          <description>Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="83"/>
          </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="62.8" spread="18.2"/>
                  </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="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infection Type</title>
          <description>Participants enrolled with either complicated intra-abdominal infection (cIAI), or complicated urinary tract infection (cUTI).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>cIAI</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>cUTI</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing ≥1 Adverse Events (AE)</title>
        <description>The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.</description>
        <time_frame>Up to 28 days</time_frame>
        <population>Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam.</population>
        <group_list>
          <group group_id="O1">
            <title>cIAI/cUTI</title>
            <description>Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing ≥1 Adverse Events (AE)</title>
          <description>The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.</description>
          <population>Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam.</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="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.1" lower_limit="63.5" upper_limit="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)</title>
        <description>The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.</description>
        <time_frame>Up to 14 days (End of Therapy Visit)</time_frame>
        <population>Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam.</population>
        <group_list>
          <group group_id="O1">
            <title>cIAI/cUTI</title>
            <description>Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)</title>
          <description>The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.</description>
          <population>Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam.</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="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="1.6" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit</title>
        <description>The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of &quot;cure&quot; or &quot;improved&quot; as determined by the investigator at the End of Therapy Visit. &quot;Cure&quot; is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. &quot;Improved&quot; is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.</description>
        <time_frame>Between Day 5 and Day 14 (End of Therapy Visit)</time_frame>
        <population>Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>cIAI</title>
            <description>Participants with cIAI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit</title>
          <description>The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of &quot;cure&quot; or &quot;improved&quot; as determined by the investigator at the End of Therapy Visit. &quot;Cure&quot; is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. &quot;Improved&quot; is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.</description>
          <population>Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7" lower_limit="67.9" upper_limit="94.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit</title>
        <description>The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to &lt;10^4 CFU/mL) of all uropathogens found at study entry.</description>
        <time_frame>Between Day 5 and Day 14 (End of Therapy Visit)</time_frame>
        <population>Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>cUTI</title>
            <description>Participants with cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit</title>
          <description>The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to &lt;10^4 CFU/mL) of all uropathogens found at study entry.</description>
          <population>Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="89.3" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit</title>
        <description>The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of &quot;cure&quot; as determined by the investigator at the Test of Cure Visit. &quot;Cure&quot; is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to &quot;preinfection status&quot;) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.</description>
        <time_frame>Between Day 10 and Day 23 (Test of Cure Visit)</time_frame>
        <population>Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>cIAI</title>
            <description>Participants with cIAI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit</title>
          <description>The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of &quot;cure&quot; as determined by the investigator at the Test of Cure Visit. &quot;Cure&quot; is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to &quot;preinfection status&quot;) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.</description>
          <population>Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.1" lower_limit="63.9" upper_limit="92.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit</title>
        <description>The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to &lt;10^4 CFU/mL) of all uropathogens found at study entry.</description>
        <time_frame>Between Day 10 and Day 23 (Test of Cure Visit)</time_frame>
        <population>Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>cUTI</title>
            <description>Participants with cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit</title>
          <description>The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to &lt;10^4 CFU/mL) of all uropathogens found at study entry.</description>
          <population>Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.</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="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.0" lower_limit="43.4" upper_limit="72.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 28 days (up to 14 days after completion of intravenous study therapy)</time_frame>
      <desc>Adverse events were reported for all participants who received at least one dose of IV study therapy.</desc>
      <group_list>
        <group group_id="E1">
          <title>cIAI/cUTI</title>
          <description>Participants with cIAI or cUTI received intravenous imipenem+cilastatin+relebactam once every 6 hours for 5-14 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Rhegmatogenous retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Renal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>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="18" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="81"/>
              </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>Subsequent to the multicenter publication (or after public disclosure of the results at www.clinicaltrials.gov if multicenter manuscript is not planned), an investigator and colleagues may publish their data independently.&#xD;
Sponsor must have opportunity to review proposed abstracts, manuscripts or presentations 45 days prior to submission for publication/presentation. Confidential information must be deleted prior to submission; this confidentiality does not include efficacy and safety results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT03293485
org study id: 7655A-017
secondary id: 173738
nct id: NCT03293485
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL,
      MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or
      complicated urinary tract infection (cUTI).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Experiencing ≥1 Adverse Events (AE)
time frame: Up to 28 days
description: The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
time frame: Up to 14 days (End of Therapy Visit)
description: The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.
measure: Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit
time frame: Between Day 5 and Day 14 (End of Therapy Visit)
description: The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of "cure" or "improved" as determined by the investigator at the End of Therapy Visit. "Cure" is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. "Improved" is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.
measure: Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit
time frame: Between Day 5 and Day 14 (End of Therapy Visit)
description: The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry.
measure: Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit
time frame: Between Day 10 and Day 23 (Test of Cure Visit)
description: The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of "cure" as determined by the investigator at the Test of Cure Visit. "Cure" is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to "preinfection status") AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed.
measure: Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit
time frame: Between Day 10 and Day 23 (Test of Cure Visit)
description: The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry.
arm group label: Imipenem+Cilastatin/Relebactam
arm group type: Experimental
description: Participants with cIAI or cUTI will receive imipenem+cilastatin/relebactam intravenous (IV) infusion once every 6 hours for 5 to 14 days
intervention type: Drug
intervention name: Imipenem+Cilastatin/Relebactam
description: Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours
arm group label: Imipenem+Cilastatin/Relebactam
other name: IMI/REL
other name: MK-7655A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: Japan
citation: Kohno S, Bando H, Yoneyama F, Kikukawa H, Kawahara K, Shirakawa M, Aoyama N, Brown M, Paschke A, Takase A. The safety and efficacy of relebactam/imipenem/cilastatin in Japanese patients with complicated intra-abdominal infection or complicated urinary tract infection: A multicenter, open-label, noncomparative phase 3 study. J Infect Chemother. 2021 Feb;27(2):262-270. doi: 10.1016/j.jiac.2020.09.032. Epub 2020 Nov 13.
PMID: 33191112
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Intraabdominal Infections
mesh term: Imipenem
mesh term: Relebactam
mesh term: Cilastatin, Imipenem Drug Combination
mesh term: Cilastatin
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 