<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/NCT03757234</url>
  </required_header>
  <id_info>
    <org_study_id>PTK0796-AP-17202</org_study_id>
    <nct_id>NCT03757234</nct_id>
  </id_info>
  <brief_title>IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis</brief_title>
  <official_title>A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of iv or iv/po Omadacycline and iv/po Levofloxacin in the Treatment of Adults With Acute Pyelonephritis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paratek Pharmaceuticals Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paratek Pharmaceuticals Inc</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or&#xD;
      iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of&#xD;
      female adults with acute pyelonephritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized (1:1:1:1:1), double-blind, double-dummy, adaptive designed, Phase 2&#xD;
      study. Based on review of the efficacy and microbiology data, the DMC modified the&#xD;
      randomization algorithm, and no further participants were enrolled in the following treatment&#xD;
      arms after May 2019: the omadacycline 200 iv/100 iv, omadacycline 200 iv/300 po or 100 iv,&#xD;
      and omadacycline 200 iv/450 po or 100 iv arms. After this change, participants were&#xD;
      randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">July 24, 2019</completion_date>
  <primary_completion_date type="Actual">June 26, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)</measure>
    <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
    <description>Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)</measure>
    <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
    <description>Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)</measure>
    <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
    <description>Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)</measure>
    <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
    <description>Participants recorded their assessments using the mPSAQ, a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with no worsening and absence of AP signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events</measure>
    <time_frame>up to approximately 28 days</time_frame>
    <description>An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study drug or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the initiation of the study drug.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Acute Pyelonephritis</condition>
  <arm_group>
    <arm_group_label>Omadacycline 200 iv/200 iv</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omadacycline 200 iv/100 iv</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omadacycline 200 iv/300 po or 100 iv</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams per oral (po). All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omadacycline 200 iv/450 po or 100 iv</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levofloxacin 750 iv/750 po or iv</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omadacycline</intervention_name>
    <description>po tablets</description>
    <arm_group_label>Omadacycline 200 iv/300 po or 100 iv</arm_group_label>
    <arm_group_label>Omadacycline 200 iv/450 po or 100 iv</arm_group_label>
    <other_name>Nuzyra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin</intervention_name>
    <description>iv solution/po tablets</description>
    <arm_group_label>Levofloxacin 750 iv/750 po or iv</arm_group_label>
    <other_name>Levaquin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omadacycline</intervention_name>
    <description>iv solution</description>
    <arm_group_label>Omadacycline 200 iv/100 iv</arm_group_label>
    <arm_group_label>Omadacycline 200 iv/200 iv</arm_group_label>
    <arm_group_label>Omadacycline 200 iv/300 po or 100 iv</arm_group_label>
    <arm_group_label>Omadacycline 200 iv/450 po or 100 iv</arm_group_label>
    <other_name>Nuzyra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female participants, age 18-65 years who have signed the informed consent form&#xD;
&#xD;
          -  Must have a qualifying acute pyelonephritis&#xD;
&#xD;
          -  Participants must not be pregnant at the time of enrollment&#xD;
&#xD;
          -  Must agree to a reliable method of birth control during the study and for 30 days&#xD;
             following the last dose of study drug&#xD;
&#xD;
          -  Must be able to comply with all of the requirements of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Symptoms of acute pyelonephritis present for longer 7 days prior to randomization&#xD;
&#xD;
          -  Infections that require antibacterial treatment for greater than 14 days&#xD;
&#xD;
          -  Evidence of suspected non-renal source of infections, vaginitis, or sexually&#xD;
             transmitted infection&#xD;
&#xD;
          -  Evidence of significant immunological disease&#xD;
&#xD;
          -  Evidence of liver impairment or disease&#xD;
&#xD;
          -  Evidence of unstable cardiac disease&#xD;
&#xD;
          -  Severe renal disease or requirement for dialysis&#xD;
&#xD;
          -  Evidence of septic shock&#xD;
&#xD;
          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to&#xD;
             levofloxacin&#xD;
&#xD;
          -  Has received an investigational drug within the past 30 days&#xD;
&#xD;
          -  Participants who are pregnant or nursing&#xD;
&#xD;
          -  Unable or unwilling to comply with the protocol requirements&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Site 201</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 202</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 203</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 204</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 301</name>
      <address>
        <city>Daugavpils</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 304</name>
      <address>
        <city>Liepāja</city>
        <zip>LV-3414</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 302</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 305</name>
      <address>
        <city>Rēzekne</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 303</name>
      <address>
        <city>Valmiera</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 409</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 408</name>
      <address>
        <city>Moscow</city>
        <zip>141435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 410</name>
      <address>
        <city>Moscow</city>
        <zip>Moscow</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 415</name>
      <address>
        <city>Penza</city>
        <zip>440026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 407</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 405</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344037</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 411</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 406</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>195067</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 402</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196247</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 412</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 403</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197374</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 414</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>198205</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 401</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>198412</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 404</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>199106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 413</name>
      <address>
        <city>Smolensk</city>
        <zip>214018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 502</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 506</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 505</name>
      <address>
        <city>Kharkiv</city>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 504</name>
      <address>
        <city>Kyiv</city>
        <zip>2660</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 503</name>
      <address>
        <city>Kyiv</city>
        <zip>4053</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 501</name>
      <address>
        <city>Lviv</city>
        <zip>79059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 507</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Georgia</country>
    <country>Latvia</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>June 8, 2020</results_first_submitted>
  <results_first_submitted_qc>July 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2020</results_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</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>Pyelonephritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levofloxacin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03757234/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03757234/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Omadacycline 200 iv/200 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
        </group>
        <group group_id="P2">
          <title>Omadacycline 200 iv/100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
        </group>
        <group group_id="P3">
          <title>Omadacycline 200 iv/300 po or 100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
        <group group_id="P4">
          <title>Omadacycline 200 iv/450 po or 100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
        <group group_id="P5">
          <title>Levofloxacin 750 iv/750 po or iv</title>
          <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed PTE Visit</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Omadacycline 200 iv/200 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
        </group>
        <group group_id="B2">
          <title>Omadacycline 200 iv/100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
        </group>
        <group group_id="B3">
          <title>Omadacycline 200 iv/300 po or 100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
        <group group_id="B4">
          <title>Omadacycline 200 iv/450 po or 100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
        <group group_id="B5">
          <title>Levofloxacin 750 iv/750 po or iv</title>
          <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
        <group group_id="B6">
          <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="75"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="17"/>
            <count group_id="B4" value="17"/>
            <count group_id="B5" value="74"/>
            <count group_id="B6" value="201"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.2" spread="14.97"/>
                    <measurement group_id="B2" value="33.9" spread="14.48"/>
                    <measurement group_id="B3" value="37.1" spread="15.97"/>
                    <measurement group_id="B4" value="38.2" spread="17.66"/>
                    <measurement group_id="B5" value="38.8" spread="14.74"/>
                    <measurement group_id="B6" value="37.9" spread="15.07"/>
                  </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="75"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="74"/>
                    <measurement group_id="B6" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_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="1"/>
                    <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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="74"/>
                    <measurement group_id="B6" value="200"/>
                  </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_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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <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="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_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="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="74"/>
                    <measurement group_id="B6" value="200"/>
                  </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="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)</title>
        <description>Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.</description>
        <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
        <population>The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Omadacycline 200 iv/200 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Omadacycline 200 iv/100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O3">
            <title>Omadacycline 200 iv/300 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>Omadacycline 200 iv/450 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>Levofloxacin 750 iv/750 po or iv</title>
            <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)</title>
          <description>Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.</description>
          <population>The intent-to-treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received 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="75"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.4</ci_lower_limit>
            <ci_upper_limit>6.9</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-9.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.8</ci_lower_limit>
            <ci_upper_limit>5.3</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-5.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.6</ci_lower_limit>
            <ci_upper_limit>8.2</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.4</ci_lower_limit>
            <ci_upper_limit>11.8</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)</title>
        <description>Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.</description>
        <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
        <population>The micro-ITT population consisted of participants in the ITT population who had an appropriately collected pretreatment baseline urine culture with at least 1 uropathogen at ≥10^5 colony forming unit (CFU)/mL and not more than 2 bacterial isolates at any colony count.</population>
        <group_list>
          <group group_id="O1">
            <title>Omadacycline 200 iv/200 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Omadacycline 200 iv/100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O3">
            <title>Omadacycline 200 iv/300 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>Omadacycline 200 iv/450 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>Levofloxacin 750 iv/750 po or iv</title>
            <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)</title>
          <description>Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.</description>
          <population>The micro-ITT population consisted of participants in the ITT population who had an appropriately collected pretreatment baseline urine culture with at least 1 uropathogen at ≥10^5 colony forming unit (CFU)/mL and not more than 2 bacterial isolates at any colony count.</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="46"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinical Success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indeterminate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-5.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.6</ci_lower_limit>
            <ci_upper_limit>12.7</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-47.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-71.3</ci_lower_limit>
            <ci_upper_limit>-6.0</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-10.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.8</ci_lower_limit>
            <ci_upper_limit>15.1</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin for comparison of the doses was set at 10%.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-36.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-62.6</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
            <estimate_desc>Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)</title>
        <description>Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.</description>
        <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
        <population>The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit with evaluable data were analyzed for this end point.</population>
        <group_list>
          <group group_id="O1">
            <title>Omadacycline 200 iv/200 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Omadacycline 200 iv/100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O3">
            <title>Omadacycline 200 iv/300 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>Omadacycline 200 iv/450 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>Levofloxacin 750 iv/750 po or iv</title>
            <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)</title>
          <description>Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.</description>
          <population>The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit with evaluable data were analyzed for this end point.</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="64"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)</title>
        <description>Participants recorded their assessments using the mPSAQ, a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with no worsening and absence of AP signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.</description>
        <time_frame>Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).</time_frame>
        <population>The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit with evaluable data were analyzed for this end point.</population>
        <group_list>
          <group group_id="O1">
            <title>Omadacycline 200 iv/200 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Omadacycline 200 iv/100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O3">
            <title>Omadacycline 200 iv/300 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>Omadacycline 200 iv/450 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>Levofloxacin 750 iv/750 po or iv</title>
            <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)</title>
          <description>Participants recorded their assessments using the mPSAQ, a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with no worsening and absence of AP signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.</description>
          <population>The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit with evaluable data were analyzed for this end point.</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="64"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events</title>
        <description>An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study drug or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the initiation of the study drug.</description>
        <time_frame>up to approximately 28 days</time_frame>
        <population>The Safety population consisted of all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Omadacycline 200 iv/200 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Omadacycline 200 iv/100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
          </group>
          <group group_id="O3">
            <title>Omadacycline 200 iv/300 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>Omadacycline 200 iv/450 po or 100 iv</title>
            <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>Levofloxacin 750 iv/750 po or iv</title>
            <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events</title>
          <description>An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study drug or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the initiation of the study drug.</description>
          <population>The Safety population consisted of all randomized participants who received at least one dose 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="75"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment Emergent Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Emergent Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 28 days</time_frame>
      <desc>The Safety Population consisted of all randomized participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omadacycline 200 iv/200 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
        </group>
        <group group_id="E2">
          <title>Omadacycline 200 iv/100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.</description>
        </group>
        <group group_id="E3">
          <title>Omadacycline 200 iv/300 po or 100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
        <group group_id="E4">
          <title>Omadacycline 200 iv/450 po or 100 iv</title>
          <description>On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
        <group group_id="E5">
          <title>Levofloxacin 750 iv/750 po or iv</title>
          <description>On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
              </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="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Renal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDra 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="16" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Asymptomatic bacteriuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Viral rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
              </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 only disclosure restriction on the Principal Investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication and require the removal of confidential information.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>In May 2019, the DMC modified the randomization algorithm based on their review of the data. After this change, participants were randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Paratek Medical Information</name_or_title>
      <organization>Paratek Pharmaceuticals, Inc.</organization>
      <phone>1-833-727-2835</phone>
      <email>medinfo@paratekpharma.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/NCT03757234
org study id: PTK0796-AP-17202
nct id: NCT03757234
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or
      iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of
      female adults with acute pyelonephritis.
This was a randomized (1:1:1:1:1), double-blind, double-dummy, adaptive designed, Phase 2
      study. Based on review of the efficacy and microbiology data, the DMC modified the
      randomization algorithm, and no further participants were enrolled in the following treatment
      arms after May 2019: the omadacycline 200 iv/100 iv, omadacycline 200 iv/300 po or 100 iv,
      and omadacycline 200 iv/450 po or 100 iv arms. After this change, participants were
      randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
description: Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as the complete resolution or significant improvement of the baseline AP signs and symptoms at the PTE visit such that no additional antimicrobial therapy is required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required or death at or before the PTE visit. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
measure: Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
description: Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of 'Success', 'Failure', or 'Indeterminate'. Participants were considered to have a microbiological response of 'Success' if the outcomes of each baseline pathogens were eradication at the PTE visit. Participants were considered to have a microbiological response of 'Failure' if the outcome for any pathogen was persistence. Participants were considered to have a microbiological response of 'Indeterminate', if the outcome of at least 1 baseline pathogen was indeterminate and there was no outcome of persistence for any baseline pathogen.
measure: Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
description: Participants recorded their assessments using the Modified Patient Symptom Assessment Questionnaire (mPSAQ), a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.
measure: Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
time frame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
description: Participants recorded their assessments using the mPSAQ, a 6-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for six pyelonephritis signs and symptoms. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 6 items, divided by the number of non-missing items, and then multiplied by 6. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 18 (worst severity/most bothersome). Number of participants with no worsening and absence of AP signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.
measure: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
time frame: up to approximately 28 days
description: An adverse event is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a study drug or in a clinical study. A treatment-emergent adverse event was defined as any adverse event that newly appeared, increased in frequency, or worsened in severity on or after the initiation of the study drug.
arm group label: Omadacycline 200 iv/200 iv
arm group type: Experimental
description: On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
arm group label: Omadacycline 200 iv/100 iv
arm group type: Experimental
description: On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.
arm group label: Omadacycline 200 iv/300 po or 100 iv
arm group type: Experimental
description: On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams per oral (po). All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
arm group label: Omadacycline 200 iv/450 po or 100 iv
arm group type: Experimental
description: On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
arm group label: Levofloxacin 750 iv/750 po or iv
arm group type: Active Comparator
description: On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.
intervention type: Drug
intervention name: Omadacycline
description: po tablets
arm group label: Omadacycline 200 iv/300 po or 100 iv
arm group label: Omadacycline 200 iv/450 po or 100 iv
other name: Nuzyra
intervention type: Drug
intervention name: Levofloxacin
description: iv solution/po tablets
arm group label: Levofloxacin 750 iv/750 po or iv
other name: Levaquin
intervention type: Drug
intervention name: Omadacycline
description: iv solution
arm group label: Omadacycline 200 iv/100 iv
arm group label: Omadacycline 200 iv/200 iv
arm group label: Omadacycline 200 iv/300 po or 100 iv
arm group label: Omadacycline 200 iv/450 po or 100 iv
other name: Nuzyra
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
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country: Georgia
country: Latvia
country: Russian Federation
country: Ukraine
responsible party type: Sponsor
mesh term: Pyelonephritis
mesh term: Levofloxacin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: In May 2019, the DMC modified the randomization algorithm based on their review of the data. After this change, participants were randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.
point of contact: 