<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/NCT03230916</url>
  </required_header>
  <id_info>
    <org_study_id>7655A-020</org_study_id>
    <secondary_id>2016-004328-43</secondary_id>
    <secondary_id>MK-7665A-020</secondary_id>
    <nct_id>NCT03230916</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)</brief_title>
  <official_title>A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of&#xD;
      imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single&#xD;
      intravenous (IV) dose of MK-7655A (a fixed ratio combination of&#xD;
      imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Actual">August 11, 2020</completion_date>
  <primary_completion_date type="Actual">July 28, 2020</primary_completion_date>
  <phase>Phase 1</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>Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma imipenem (IMI) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IMI Maximum Concentration (Cmax)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Maximum plasma concentration (Cmax) of IMI was calculated. Cmax is the peak plasma concentration of study drug after administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IMI Central Volume of Distribution (Vc)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Central volume of distribution (Vc) of plasma IMI was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IMI Clearance (CL)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Systemic clearance (CL) of plasma IMI was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IMI Percentage of Time Above the Minimum Concentration (%TMIC)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Percentage of time spent above the minimum inhibitory concentration (%TMIC) of plasma IMI was calculated. %TMIC is defined as the percentage of time (in hours) in which the lowest concentration of a study drug, completely inhibits growth of the specific organism being tested.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relebactam (REL) AUC0-∞</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma relebactam (REL) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>REL Maximum Concentration (Cmax)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Maximum plasma concentration (Cmax) of REL was calculated. Cmax is the peak plasma concentration of study drug after administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>REL Clearance (CL)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Systemic clearance (CL) of plasma REL was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>REL Central Volume of Distribution (Vc)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Central volume of distribution (Vc) of plasma REL was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cilastatin (CIL) AUC0-∞</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma cilastatin (CIL) was not calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CIL Time to Maximum Concentration (Tmax)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Time to maximum plasma concentration (Tmax) of CIL was determined. Tmax is defined as the time after drug administration at which peak drug concentration in plasma occurs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CIL Concentration at End of Infusion (Ceoi)</measure>
    <time_frame>30 min after the start of infusion for Cohort 1; 60 min after the start of infusion for Cohorts 2-5</time_frame>
    <description>Concentration at end of infusion (Ceoi) of plasma CIL was determined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CIL Terminal Half-Life (t1/2)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Terminal half-life (t1/2) of plasma CIL was not calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CIL Clearance (CL)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
    <description>Systemic clearance (CL) of plasma CIL was not calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CIL Volume of Distribution (Vss)</measure>
    <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to12 hrs after start of DI for Cohort 5</time_frame>
    <description>Volume of distribution (Vss) of plasma CIL was not calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced an Adverse Event (AE)</measure>
    <time_frame>Up to 17 days</time_frame>
    <description>Number of participants with one or more AEs was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Study Drug Due to an AE</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of participants who discontinued study drug due to an AE was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Suspected or Documented Gram-negative Bacterial Infection</condition>
  <arm_group>
    <arm_group_label>IMI/REL FDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Imipenem/Cilastatin/Relebactam (IMI/REL) administered as a single fixed 2:1 ratio of imipenem/cilastatin to relebactam, with a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IMI/REL FDC</intervention_name>
    <description>IMI/REL is supplied as a single fixed dose combination (FDC) vial; which is administered at a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).</description>
    <arm_group_label>IMI/REL FDC</arm_group_label>
    <other_name>MK-7655A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a parent or legally acceptable representative (LAR) who provides written informed&#xD;
             consent for the trial on the participant's behalf.&#xD;
&#xD;
          -  Aged from birth to &lt;18 years old.&#xD;
&#xD;
          -  Is hospitalized, currently receiving antibacterial treatment for confirmed or&#xD;
             suspected Gram-negative bacterial infection, and expected to require hospitalization&#xD;
             until at least 24 hours after completion of study drug administration.&#xD;
&#xD;
          -  Is not of reproductive potential; but if of reproductive potential, agrees to avoid&#xD;
             becoming pregnant or impregnating a partner from the time of consent through 24 hours&#xD;
             after completion of study drug administration.&#xD;
&#xD;
          -  Has clinically stable renal function at the time of screening that is judged to be&#xD;
             within acceptable ranges.&#xD;
&#xD;
          -  Has sufficient intravascular access to receive study drug through an existing&#xD;
             peripheral or central line.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a personal history of hypersensitivity to imipenem/cilastatin (IMI) or to any of&#xD;
             the following: any carbapenem, cephalosporin, penicillin, or other β-lactam agent; or&#xD;
             other β-lactamase inhibitors (BLIs) e.g. tazobactam, sulbactam, clavulanic acid,&#xD;
             avibactam.&#xD;
&#xD;
          -  Female is currently pregnant or breast feeding or has a positive serum β-human&#xD;
             chorionic gonadotropin (β-hCG) pregnancy test.&#xD;
&#xD;
          -  Has a history of a seizure disorder requiring ongoing treatment with anti-convulsive&#xD;
             therapy or prior treatment with anti-convulsive therapy within the last 3 years.&#xD;
&#xD;
          -  Has used or plans to use valproic acid or divalproex sodium within 2 weeks prior to&#xD;
             screening or at any point between screening and 24 hours after the completion of study&#xD;
             drug infusion.&#xD;
&#xD;
          -  Has received treatment or plans to receive treatment with any carbapenem antibiotic&#xD;
             within 48 hours prior to initiation of study drug infusion or at any point between&#xD;
             administration of study drug and the last PK sample collection.&#xD;
&#xD;
          -  Has used or plans to use any of the following medications, which are organic anion&#xD;
             transporter (OAT) 1 or OAT3 inhibitors, within 1 week prior to screening or at any&#xD;
             point between screening and the last PK sample collection: cimetidine, probenecid,&#xD;
             indomethacin, mefenamic acid, furosemide or other loop diuretics (eg, bumetanide,&#xD;
             torsemide, ethacrynic acid), angiotensin receptor blockers (eg, valsartan), and&#xD;
             ketorolac.&#xD;
&#xD;
          -  Is currently participating in or has participated in an interventional clinical trial&#xD;
             with an investigational compound or device within 30 days prior to screening.&#xD;
&#xD;
          -  Has enrolled previously in the current trial and been discontinued, or has received&#xD;
             REL for any other reason.&#xD;
&#xD;
          -  Has a current diagnosis of cystic fibrosis, meningitis, or severe sepsis.&#xD;
&#xD;
          -  Is expected to survive less than 72 hours after completion of study drug&#xD;
             administration.&#xD;
&#xD;
          -  Has a history of clinically significant renal, hepatic, or hemodynamic instability.&#xD;
&#xD;
          -  Plans to use cardiopulmonary bypass, extracorporeal membrane oxygenation,&#xD;
             hemodialysis, or peritoneal dialysis during the study.&#xD;
&#xD;
          -  For participants that are 2 to 17 years of age only: weighs outside of the 5th to 95th&#xD;
             percentile based on age.&#xD;
&#xD;
          -  Is, at the time of signing informed consent, a user of recreational or illicit drugs&#xD;
             or has had a recent history (within the last year) of drug or alcohol abuse or&#xD;
             dependence.&#xD;
&#xD;
          -  Has a planned blood transfusion within 24 hours of study drug administration or&#xD;
             expected before the end of the PK sampling.&#xD;
&#xD;
          -  Has had significant blood loss (≥5% of total blood volume) within 4 weeks before the&#xD;
             screening visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>17 Years</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>Arkansas Children's Hospital ( Site 1311)</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Orange County ( Site 1301)</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital-San Diego ( Site 1305)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Our Lady of the Lake Hospital ( Site 1304)</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital ( Site 1322)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center ( Site 1317)</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia ( Site 1318)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Childrens Hospital ( Site 1321)</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Pazardjik AD ( Site 0208)</name>
      <address>
        <city>Pazardjik</city>
        <state>Pazardzhik</state>
        <zip>4400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Deva Maria. EOOD ( Site 0209)</name>
      <address>
        <city>Burgas</city>
        <zip>8127</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Dr. Georgi Stranski EAD ( Site 0211)</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Kanev AD ( Site 0203)</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Kanev AD ( Site 0212)</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe ( Site 0301)</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Medellin Luz Castro de Gutierrez ( Site 0303)</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>500515</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Valle del Lili ( Site 0300)</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760032</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Thessaloniki Hippokrateio ( Site 1402)</name>
      <address>
        <city>Thessaloniki</city>
        <zip>546 42</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus Universitetssykehus HF ( Site 0903)</name>
      <address>
        <city>Loerenskog</city>
        <state>Akershus</state>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger Universitetssykehus, Helse Stavanger ( Site 0901)</name>
      <address>
        <city>Stavanger</city>
        <state>Rogaland</state>
        <zip>4011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital ( Site 0900)</name>
      <address>
        <city>Trondheim</city>
        <state>Sor-Trondelag</state>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland Universitetssjukehus ( Site 0902)</name>
      <address>
        <city>Bergen</city>
        <state>Vestfold</state>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi ( Site 1000)</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1002)</name>
      <address>
        <city>Lomianki</city>
        <state>Mazowieckie</state>
        <zip>05-092</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1214)</name>
      <address>
        <city>Dnipro</city>
        <state>Dnipropetrovska Oblast</state>
        <zip>49100</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kharkiv City Children Hospital 16 ( Site 1200)</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkivska Oblast</state>
        <zip>61075</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1213)</name>
      <address>
        <city>Kyiv</city>
        <state>Kyivska Oblast</state>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odessa Regional Children Clinical Hospital ( Site 1203)</name>
      <address>
        <city>Odesa</city>
        <state>Odeska Oblast</state>
        <zip>65031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children City Clinical Hospital ( Site 1215)</name>
      <address>
        <city>Poltava</city>
        <state>Poltavska Oblast</state>
        <zip>36004</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zaporizhzhya Regional Clinical Childrens Hospital ( Site 1202)</name>
      <address>
        <city>Zaporizhzhya</city>
        <state>Zaporizka Oblast</state>
        <zip>69063</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Hospital for Children ( Site 1101)</name>
      <address>
        <city>Bristol</city>
        <state>Bristol, City Of</state>
        <zip>BS2 8AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust ( Site 1100)</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Georges University Hospital NHS Foundation Trust ( Site 1103)</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Northern Children s Hospital ( Site 1102)</name>
      <address>
        <city>Newcastle</city>
        <state>Newcastle Upon Tyne</state>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Colombia</country>
    <country>Greece</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>July 21, 2021</results_first_submitted>
  <results_first_submitted_qc>October 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 13, 2021</results_first_posted>
  <last_update_submitted>October 28, 2021</last_update_submitted>
  <last_update_submitted_qc>October 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 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>Bacterial Infections</mesh_term>
    <mesh_term>Gram-Negative Bacterial Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Relebactam</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>August 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03230916/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Note: Participant information is shown by age cohort and drug dosage to provide clinically-similar groups for analysis of participant baseline characteristics and safety data. Participant information in pharmacokinetic (PK) outcome measures is shown by age cohort, drug dose received and infusion time in order to provide appropriate and clinically discrete groups for PK analysis and modeling.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: IMI/REL 15/7.5 mg/kg</title>
          <description>Adolescents (age 12 to &lt;18 years) administered with a single intravenous (IV) 30-minute infusion dose of imipenem/cilastatin/relebactam (IMI/REL) at 15/7.5 mg/kg, up to maximum dose of 500/250 mg</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2: IMI/REL 15/7.5 mg/kg</title>
          <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3: IMI/REL 15/7.5 mg/kg</title>
          <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
          <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="P5">
          <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
          <description>Toddlers (1 to &lt;2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="P6">
          <title>Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg</title>
          <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="P7">
          <title>Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg</title>
          <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="P8">
          <title>Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg</title>
          <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="P9">
          <title>Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg</title>
          <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="P10">
          <title>Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg</title>
          <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="P11">
          <title>Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg</title>
          <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="3"/>
                <participants group_id="P11" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="3"/>
                <participants group_id="P11" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="3"/>
                <participants group_id="P11" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: IMI/REL 15/7.5 mg/kg</title>
          <description>Adolescents (age 12 to &lt;18 years) administered with a single intravenous (IV) 30-minute infusion dose of imipenem/cilastatin/relebactam (IMI/REL) at 15/7.5 mg/kg, up to maximum dose of 500/250 mg</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2: IMI/REL 15/7.5 mg/kg</title>
          <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3: IMI/REL 15/7.5 mg/kg</title>
          <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="B4">
          <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
          <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="B5">
          <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
          <description>Toddlers (1 to &lt;2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="B6">
          <title>Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg</title>
          <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="B7">
          <title>Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg</title>
          <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="B8">
          <title>Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg</title>
          <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="B9">
          <title>Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg</title>
          <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="B10">
          <title>Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg</title>
          <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="B11">
          <title>Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg</title>
          <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="B12">
          <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="7"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="3"/>
            <count group_id="B8" value="2"/>
            <count group_id="B9" value="2"/>
            <count group_id="B10" value="3"/>
            <count group_id="B11" value="4"/>
            <count group_id="B12" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>In utero</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preterm newborn infants (gestational age &lt; 37 wks)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Newborns (0-27 days)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Infants and toddlers (28 days-23 months)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Children (2-11 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adolescents (12-17 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adults (18-64 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>From 65-84 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>85 years and over</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </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="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="19"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞)</title>
        <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma imipenem (IMI) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI AUC0-∞</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞)</title>
          <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma imipenem (IMI) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI AUC0-∞</population>
          <units>μM*hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.7" spread="19.8"/>
                    <measurement group_id="O2" value="153.2" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="219.4" spread="39.2"/>
                    <measurement group_id="O4" value="139.4" spread="26.6"/>
                    <measurement group_id="O5" value="140" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="156" spread="18.9"/>
                    <measurement group_id="O7" value="163" spread="31.2"/>
                    <measurement group_id="O8" value="95.4" spread="39.3"/>
                    <measurement group_id="O9" value="219.2" spread="39.6"/>
                    <measurement group_id="O10" value="152.5" spread="14.1"/>
                    <measurement group_id="O11" value="271.3" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IMI Maximum Concentration (Cmax)</title>
        <description>Maximum plasma concentration (Cmax) of IMI was calculated. Cmax is the peak plasma concentration of study drug after administration.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI Cmax</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>IMI Maximum Concentration (Cmax)</title>
          <description>Maximum plasma concentration (Cmax) of IMI was calculated. Cmax is the peak plasma concentration of study drug after administration.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI Cmax</population>
          <units>μM</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.6" spread="16.4"/>
                    <measurement group_id="O2" value="126.0" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="123.0" spread="20.6"/>
                    <measurement group_id="O4" value="114.2" spread="9.2"/>
                    <measurement group_id="O5" value="110.6" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="150.3" spread="6.7"/>
                    <measurement group_id="O7" value="125.1" spread="25.2"/>
                    <measurement group_id="O8" value="64.9" spread="29.6"/>
                    <measurement group_id="O9" value="127.7" spread="36.0"/>
                    <measurement group_id="O10" value="79.4" spread="26.4"/>
                    <measurement group_id="O11" value="119.8" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IMI Central Volume of Distribution (Vc)</title>
        <description>Central volume of distribution (Vc) of plasma IMI was calculated.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI Vc</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to Infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>IMI Central Volume of Distribution (Vc)</title>
          <description>Central volume of distribution (Vc) of plasma IMI was calculated.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI Vc</population>
          <units>Liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.27" spread="16.2"/>
                    <measurement group_id="O2" value="8.00" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="4.33" spread="5.2"/>
                    <measurement group_id="O4" value="9.60" spread="2.4"/>
                    <measurement group_id="O5" value="8.70" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="3.49" spread="19.6"/>
                    <measurement group_id="O7" value="2.49" spread="34.6"/>
                    <measurement group_id="O8" value="2.39" spread="53.2"/>
                    <measurement group_id="O9" value="1.52" spread="35.0"/>
                    <measurement group_id="O10" value="1.06" spread="29.6"/>
                    <measurement group_id="O11" value="0.95" spread="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IMI Clearance (CL)</title>
        <description>Systemic clearance (CL) of plasma IMI was calculated.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI CL</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>IMI Clearance (CL)</title>
          <description>Systemic clearance (CL) of plasma IMI was calculated.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI CL</population>
          <units>L/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.58" spread="18.4"/>
                    <measurement group_id="O2" value="9.60" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="5.25" spread="9.2"/>
                    <measurement group_id="O4" value="11.67" spread="27.6"/>
                    <measurement group_id="O5" value="11.74" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="5.31" spread="29.7"/>
                    <measurement group_id="O7" value="4.43" spread="45.2"/>
                    <measurement group_id="O8" value="3.31" spread="60.1"/>
                    <measurement group_id="O9" value="1.70" spread="48.1"/>
                    <measurement group_id="O10" value="1.10" spread="26.2"/>
                    <measurement group_id="O11" value="0.66" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IMI Percentage of Time Above the Minimum Concentration (%TMIC)</title>
        <description>Percentage of time spent above the minimum inhibitory concentration (%TMIC) of plasma IMI was calculated. %TMIC is defined as the percentage of time (in hours) in which the lowest concentration of a study drug, completely inhibits growth of the specific organism being tested.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI %TMIC</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>IMI Percentage of Time Above the Minimum Concentration (%TMIC)</title>
          <description>Percentage of time spent above the minimum inhibitory concentration (%TMIC) of plasma IMI was calculated. %TMIC is defined as the percentage of time (in hours) in which the lowest concentration of a study drug, completely inhibits growth of the specific organism being tested.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI %TMIC</population>
          <units>Percentage of time</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.5" spread="17.1"/>
                    <measurement group_id="O2" value="58.3" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="80.3" spread="26.7"/>
                    <measurement group_id="O4" value="61.6" spread="25.1"/>
                    <measurement group_id="O5" value="56.7" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="50.1" spread="15.7"/>
                    <measurement group_id="O7" value="57.7" spread="18.8"/>
                    <measurement group_id="O8" value="50.4" spread="30.5"/>
                    <measurement group_id="O9" value="73.9" spread="19.7"/>
                    <measurement group_id="O10" value="70.2" spread="10.6"/>
                    <measurement group_id="O11" value="93.7" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Relebactam (REL) AUC0-∞</title>
        <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma relebactam (REL) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL AUC0-∞</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>Relebactam (REL) AUC0-∞</title>
          <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma relebactam (REL) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL AUC0-∞</population>
          <units>μM*hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.1" spread="20.0"/>
                    <measurement group_id="O2" value="105.6" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="123.8" spread="59.5"/>
                    <measurement group_id="O4" value="90.3" spread="35.1"/>
                    <measurement group_id="O5" value="80.2" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="85.7" spread="32.4"/>
                    <measurement group_id="O7" value="81.7" spread="42.0"/>
                    <measurement group_id="O8" value="52.8" spread="33.6"/>
                    <measurement group_id="O9" value="126.6" spread="53.7"/>
                    <measurement group_id="O10" value="91.8" spread="18.3"/>
                    <measurement group_id="O11" value="220.7" spread="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>REL Maximum Concentration (Cmax)</title>
        <description>Maximum plasma concentration (Cmax) of REL was calculated. Cmax is the peak plasma concentration of study drug after administration.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Cmax</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>REL Maximum Concentration (Cmax)</title>
          <description>Maximum plasma concentration (Cmax) of REL was calculated. Cmax is the peak plasma concentration of study drug after administration.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Cmax</population>
          <units>μM</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.33" spread="23.0"/>
                    <measurement group_id="O2" value="86.52" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="60.32" spread="30.7"/>
                    <measurement group_id="O4" value="57.44" spread="26.1"/>
                    <measurement group_id="O5" value="48.73" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="59.05" spread="9.08"/>
                    <measurement group_id="O7" value="48.59" spread="22.9"/>
                    <measurement group_id="O8" value="32.74" spread="15.0"/>
                    <measurement group_id="O9" value="59.55" spread="17.1"/>
                    <measurement group_id="O10" value="34.22" spread="17.3"/>
                    <measurement group_id="O11" value="61.04" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>REL Clearance (CL)</title>
        <description>Systemic clearance (CL) of plasma REL was calculated.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL CL</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>REL Clearance (CL)</title>
          <description>Systemic clearance (CL) of plasma REL was calculated.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL CL</population>
          <units>L/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.98" spread="20.7"/>
                    <measurement group_id="O2" value="6.10" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="3.96" spread="28.9"/>
                    <measurement group_id="O4" value="8.03" spread="35.7"/>
                    <measurement group_id="O5" value="8.65" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="4.20" spread="40.8"/>
                    <measurement group_id="O7" value="3.65" spread="54.1"/>
                    <measurement group_id="O8" value="2.56" spread="54.5"/>
                    <measurement group_id="O9" value="1.27" spread="62.9"/>
                    <measurement group_id="O10" value="0.74" spread="27.0"/>
                    <measurement group_id="O11" value="0.35" spread="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>REL Central Volume of Distribution (Vc)</title>
        <description>Central volume of distribution (Vc) of plasma REL was calculated.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Vc</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>REL Central Volume of Distribution (Vc)</title>
          <description>Central volume of distribution (Vc) of plasma REL was calculated.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Vc</population>
          <units>Liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.58" spread="17.2"/>
                    <measurement group_id="O2" value="6.76" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O3" value="4.95" spread="1.6"/>
                    <measurement group_id="O4" value="9.81" spread="6.1"/>
                    <measurement group_id="O5" value="9.38" spread="NA">NA=not calculated</measurement>
                    <measurement group_id="O6" value="3.83" spread="13.8"/>
                    <measurement group_id="O7" value="2.88" spread="27.4"/>
                    <measurement group_id="O8" value="2.43" spread="38.8"/>
                    <measurement group_id="O9" value="1.70" spread="21.1"/>
                    <measurement group_id="O10" value="1.21" spread="24.6"/>
                    <measurement group_id="O11" value="0.90" spread="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cilastatin (CIL) AUC0-∞</title>
        <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma cilastatin (CIL) was not calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500-250 mg 30-minute Infusion</title>
            <description>Cohort 1: IMI/REL 500/250 mg 30-minute infusion Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>Cilastatin (CIL) AUC0-∞</title>
          <description>Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma cilastatin (CIL) was not calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.</description>
          <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CIL Time to Maximum Concentration (Tmax)</title>
        <description>Time to maximum plasma concentration (Tmax) of CIL was determined. Tmax is defined as the time after drug administration at which peak drug concentration in plasma occurs.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Tmax</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>CIL Time to Maximum Concentration (Tmax)</title>
          <description>Time to maximum plasma concentration (Tmax) of CIL was determined. Tmax is defined as the time after drug administration at which peak drug concentration in plasma occurs.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Tmax</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="7"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" lower_limit="0.52" upper_limit="0.58"/>
                    <measurement group_id="O2" value="0.53" lower_limit="0.53" upper_limit="0.53"/>
                    <measurement group_id="O3" value="1.1" lower_limit="1.1" upper_limit="1.1"/>
                    <measurement group_id="O4" value="0.58" lower_limit="0.57" upper_limit="0.58"/>
                    <measurement group_id="O5" value="1.1" lower_limit="1.1" upper_limit="1.1"/>
                    <measurement group_id="O6" value="0.58" lower_limit="0.57" upper_limit="0.58"/>
                    <measurement group_id="O7" value="1.1" lower_limit="1.1" upper_limit="1.1"/>
                    <measurement group_id="O8" value="1.1" lower_limit="1.1" upper_limit="1.7"/>
                    <measurement group_id="O9" value="1.2" lower_limit="1.1" upper_limit="1.2"/>
                    <measurement group_id="O10" value="1.1" lower_limit="1.1" upper_limit="1.2"/>
                    <measurement group_id="O11" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CIL Concentration at End of Infusion (Ceoi)</title>
        <description>Concentration at end of infusion (Ceoi) of plasma CIL was determined.</description>
        <time_frame>30 min after the start of infusion for Cohort 1; 60 min after the start of infusion for Cohorts 2-5</time_frame>
        <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Ceoi</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>CIL Concentration at End of Infusion (Ceoi)</title>
          <description>Concentration at end of infusion (Ceoi) of plasma CIL was determined.</description>
          <population>All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Ceoi</population>
          <units>μM</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
                <count group_id="O10" value="7"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9" spread="41.0"/>
                    <measurement group_id="O2" value="122" spread="NA">Geometric coefficient of variation cannot be calculated for a sample size of 1.</measurement>
                    <measurement group_id="O3" value="111" spread="51"/>
                    <measurement group_id="O4" value="80.5" spread="22"/>
                    <measurement group_id="O5" value="74.8" spread="NA">Geometric coefficient of variation cannot be calculated for a sample size of 1.</measurement>
                    <measurement group_id="O6" value="102" spread="32"/>
                    <measurement group_id="O7" value="80.9" spread="62"/>
                    <measurement group_id="O8" value="37.0" spread="64.0"/>
                    <measurement group_id="O9" value="94.5" spread="42.0"/>
                    <measurement group_id="O10" value="63.6" spread="28.0"/>
                    <measurement group_id="O11" value="107.0" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CIL Terminal Half-Life (t1/2)</title>
        <description>Terminal half-life (t1/2) of plasma CIL was not calculated.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>CIL Terminal Half-Life (t1/2)</title>
          <description>Terminal half-life (t1/2) of plasma CIL was not calculated.</description>
          <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CIL Clearance (CL)</title>
        <description>Systemic clearance (CL) of plasma CIL was not calculated.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5</time_frame>
        <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>CIL Clearance (CL)</title>
          <description>Systemic clearance (CL) of plasma CIL was not calculated.</description>
          <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CIL Volume of Distribution (Vss)</title>
        <description>Volume of distribution (Vss) of plasma CIL was not calculated.</description>
        <time_frame>30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to12 hrs after start of DI for Cohort 5</time_frame>
        <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: IMI/REL 500/250 mg 30-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 2: IMI/REL 500/250 mg 60-minute Infusion</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: IMI/REL 10/5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: IMI/REL 15/7.5 mg/kg</title>
            <description>Neonates to infants (birth to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>CIL Volume of Distribution (Vss)</title>
          <description>Volume of distribution (Vss) of plasma CIL was not calculated.</description>
          <population>Due to sparse PK sampling schedule, per participant data could not be calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced an Adverse Event (AE)</title>
        <description>Number of participants with one or more AEs was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.</description>
        <time_frame>Up to 17 days</time_frame>
        <population>All allocated participants who received infusion (including partial doses) of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 15/7.5 mg/kg</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to &lt;2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg</title>
            <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg</title>
            <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg</title>
            <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg</title>
            <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg</title>
            <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg</title>
            <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced an Adverse Event (AE)</title>
          <description>Number of participants with one or more AEs was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.</description>
          <population>All allocated participants who received infusion (including partial doses) of study drug</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="3"/>
                <count group_id="O11" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Study Drug Due to an AE</title>
        <description>Number of participants who discontinued study drug due to an AE was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.</description>
        <time_frame>Day 1</time_frame>
        <population>All allocated participants who received infusion (including partial doses) of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: IMI/REL 15/7.5 mg/kg</title>
            <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: IMI/REL 15/7.5 mg/kg</title>
            <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3: IMI/REL 15/7.5 mg/kg</title>
            <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
            <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O5">
            <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
            <description>Toddlers (1 to &lt;2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O6">
            <title>Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg</title>
            <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O7">
            <title>Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg</title>
            <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O8">
            <title>Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg</title>
            <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
          </group>
          <group group_id="O9">
            <title>Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg</title>
            <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O10">
            <title>Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg</title>
            <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
          <group group_id="O11">
            <title>Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg</title>
            <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Drug Due to an AE</title>
          <description>Number of participants who discontinued study drug due to an AE was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.</description>
          <population>All allocated participants who received infusion (including partial doses) of study drug</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="2"/>
                <count group_id="O9" value="2"/>
                <count group_id="O10" value="3"/>
                <count group_id="O11" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 17 days (AE reporting), up to 19 days (all-cause mortality)</time_frame>
      <desc>The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: IMI/REL 15/7.5 mg/kg</title>
          <description>Adolescents (age 12 to &lt;18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2: IMI/REL 15/7.5 mg/kg</title>
          <description>Older children (6 to &lt;12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3: IMI/REL 15/7.5 mg/kg</title>
          <description>Younger children (2 to &lt;6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="E4">
          <title>Cohort 4: IMI/REL 10/5 mg/kg</title>
          <description>Infants (3 months to &lt;1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="E5">
          <title>Cohort 4: IMI/REL 15/7.5 mg/kg</title>
          <description>Toddlers (1 to &lt;2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="E6">
          <title>Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg</title>
          <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="E7">
          <title>Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg</title>
          <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="E8">
          <title>Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg</title>
          <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg</description>
        </group>
        <group group_id="E9">
          <title>Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg</title>
          <description>Young infants (4 weeks to &lt;3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="E10">
          <title>Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg</title>
          <description>Older neonates (1 to &lt;4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
        <group group_id="E11">
          <title>Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg</title>
          <description>Younger neonates (&lt;1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Thrombocytoses</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </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>The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials Disclosure</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/NCT03230916
org study id: 7655A-020
secondary id: 2016-004328-43
secondary id: MK-7665A-020
nct id: NCT03230916
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of
      imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single
      intravenous (IV) dose of MK-7655A (a fixed ratio combination of
      imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma imipenem (IMI) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
measure: IMI Maximum Concentration (Cmax)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Maximum plasma concentration (Cmax) of IMI was calculated. Cmax is the peak plasma concentration of study drug after administration.
measure: IMI Central Volume of Distribution (Vc)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Central volume of distribution (Vc) of plasma IMI was calculated.
measure: IMI Clearance (CL)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Systemic clearance (CL) of plasma IMI was calculated.
measure: IMI Percentage of Time Above the Minimum Concentration (%TMIC)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Percentage of time spent above the minimum inhibitory concentration (%TMIC) of plasma IMI was calculated. %TMIC is defined as the percentage of time (in hours) in which the lowest concentration of a study drug, completely inhibits growth of the specific organism being tested.
measure: Relebactam (REL) AUC0-∞
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma relebactam (REL) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
measure: REL Maximum Concentration (Cmax)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Maximum plasma concentration (Cmax) of REL was calculated. Cmax is the peak plasma concentration of study drug after administration.
measure: REL Clearance (CL)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Systemic clearance (CL) of plasma REL was calculated.
measure: REL Central Volume of Distribution (Vc)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Central volume of distribution (Vc) of plasma REL was calculated.
measure: Cilastatin (CIL) AUC0-∞
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma cilastatin (CIL) was not calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
measure: CIL Time to Maximum Concentration (Tmax)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Time to maximum plasma concentration (Tmax) of CIL was determined. Tmax is defined as the time after drug administration at which peak drug concentration in plasma occurs.
measure: CIL Concentration at End of Infusion (Ceoi)
time frame: 30 min after the start of infusion for Cohort 1; 60 min after the start of infusion for Cohorts 2-5
description: Concentration at end of infusion (Ceoi) of plasma CIL was determined.
measure: CIL Terminal Half-Life (t1/2)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Terminal half-life (t1/2) of plasma CIL was not calculated.
measure: CIL Clearance (CL)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
description: Systemic clearance (CL) of plasma CIL was not calculated.
measure: CIL Volume of Distribution (Vss)
time frame: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to12 hrs after start of DI for Cohort 5
description: Volume of distribution (Vss) of plasma CIL was not calculated.
measure: Number of Participants Who Experienced an Adverse Event (AE)
time frame: Up to 17 days
description: Number of participants with one or more AEs was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.
measure: Number of Participants Who Discontinued Study Drug Due to an AE
time frame: Day 1
description: Number of participants who discontinued study drug due to an AE was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.
arm group label: IMI/REL FDC
arm group type: Experimental
description: Imipenem/Cilastatin/Relebactam (IMI/REL) administered as a single fixed 2:1 ratio of imipenem/cilastatin to relebactam, with a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).
intervention type: Drug
intervention name: IMI/REL FDC
description: IMI/REL is supplied as a single fixed dose combination (FDC) vial; which is administered at a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).
arm group label: IMI/REL FDC
other name: MK-7655A
criteria: 
gender: All
minimum age: 1 Day
maximum age: 17 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: Bulgaria
country: Colombia
country: Greece
country: Norway
country: Poland
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
mesh term: Gram-Negative Bacterial Infections
mesh term: Relebactam
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: 
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outcome list: 
reported events: 
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