<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/NCT03840148</url>
  </required_header>
  <id_info>
    <org_study_id>VNRX-5133-201</org_study_id>
    <secondary_id>2018-001451-13</secondary_id>
    <nct_id>NCT03840148</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections</brief_title>
  <acronym>CERTAIN-1</acronym>
  <official_title>A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Venatorx Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Venatorx 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>
      This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem&#xD;
      in both eradication of bacteria and in symptomatic response in patients with cUTIs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2019</start_date>
  <completion_date type="Actual">December 14, 2021</completion_date>
  <primary_completion_date type="Actual">December 14, 2021</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of microbiological eradication and symptomatic clinical success in the microbiological intent-to-treat (microITT) population at test of cure (TOC)</measure>
    <time_frame>Days 19-23</time_frame>
    <description>Microbiologic eradication is defined as demonstration that any gram negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to &lt;10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiological and symptomatic success at test of cure (TOC)</measure>
    <time_frame>Days 19-23</time_frame>
    <description>The proportion of patients with both microbiological success and symptomatic clinical success at TOC in the extended microITT population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical and microbiological success at end of treatment (EOT) and last follow-up (LFU)</measure>
    <time_frame>24 hours after last IV dose, Days 28-35</time_frame>
    <description>The proportion of patients with both microbiological success and symptomatic clinical success at EOT and LFU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per-patient microbiological success at EOT, TOC and LFU</measure>
    <time_frame>Within 24 hours of last IV dose, Days 19-23, Days 28-35</time_frame>
    <description>The proportion of patients with per-patient microbiological success at EOT, TOC and LFU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with symptomatic clinical success at EOT, TOC and LFU</measure>
    <time_frame>Within 24 hours of last IV dose, Days 19-23, Days 28-35</time_frame>
    <description>The proportion of patients with symptomatic clinical success at EOT, TOC and LFU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator opinion of clinical success at TOC</measure>
    <time_frame>Days 19-23</time_frame>
    <description>The proportion of patients with clinical success based on investigator opinion at TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per-pathogen microbiological success at EOT, TOC and LFU</measure>
    <time_frame>Within 24 hours of last IV dose, Days 19-23, Days 28-35</time_frame>
    <description>The proportion of patients with per-pathogen microbiological success at EOT, TOC and LFU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological and clinical success in cefepime-resistant pathogens at EOT, TOC and LFU</measure>
    <time_frame>Within 24 hours of last IV dose, Days 19-23, Days 28-35</time_frame>
    <description>The proportion of patients with both microbiological success and symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU</measure>
    <time_frame>Within 24 hours of last IV dose, Days 19-23, Days 28-35</time_frame>
    <description>The proportion of patients with per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU</measure>
    <time_frame>Within 24 hours of last IV dose, Days 19-23, Days 28-35</time_frame>
    <description>The proportion of patients with per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU cefepime-resistant pathogens</measure>
    <time_frame>Within 24 hours of last IV dose, Days 19-23, Days 28-35</time_frame>
    <description>The proportion of patients with symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Days 35</time_frame>
    <description>Percent of participants experiencing adverse events.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with serious adverse events</measure>
    <time_frame>Days 35</time_frame>
    <description>Percent of participants experiencing serious adverse events.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">661</enrollment>
  <condition>Urinary Tract Infections</condition>
  <condition>Acute Pyelonephritis</condition>
  <arm_group>
    <arm_group_label>Cefepime/VNRX-5133 (taniborbactam)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meropenem</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Meropenem will be administered q8h IV over 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefepime/VNRX-5133 (taniborbactam)</intervention_name>
    <description>Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.</description>
    <arm_group_label>Cefepime/VNRX-5133 (taniborbactam)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Meropenem</intervention_name>
    <description>Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.</description>
    <arm_group_label>Meropenem</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male and female&#xD;
&#xD;
          -  Documented diagnosis of pyuria&#xD;
&#xD;
          -  Documented diagnosis of cUTI or Acute Pyelonephritis (AP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours during&#xD;
             the previous 72 hours prior to randomization&#xD;
&#xD;
          -  A urine culture result is resistant to meropenem or a gram negative pathogen is not&#xD;
             identified or more than 2 microorganisms are isolated or a confirmed fungal UTI is&#xD;
             identified&#xD;
&#xD;
          -  Required use of nonstudy systemic bacterial therapy&#xD;
&#xD;
          -  Suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually&#xD;
             transmitted disease&#xD;
&#xD;
          -  Patients with perinephric or renal abscess&#xD;
&#xD;
          -  Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis&#xD;
&#xD;
          -  Abnormal labs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Site 184003</name>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 184002</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 184001</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>184012</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 103203</name>
      <address>
        <city>Córdoba</city>
        <zip>X5016KEH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 107601</name>
      <address>
        <city>Belo Horizonte</city>
        <zip>30150-221</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 107608</name>
      <address>
        <city>San Paolo</city>
        <zip>04039-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110009</name>
      <address>
        <city>Gabrovo</city>
        <zip>5300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110002</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110007</name>
      <address>
        <city>Plovdiv</city>
        <zip>4003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110003</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110010</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110004</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110005</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110008</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110001</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156022</name>
      <address>
        <city>Baotou</city>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156002</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156006</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156015</name>
      <address>
        <city>Chendu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156011</name>
      <address>
        <city>Chongqing</city>
        <zip>400016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156012</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156004</name>
      <address>
        <city>Dalian</city>
        <zip>116023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156030</name>
      <address>
        <city>Fujian</city>
        <zip>362202</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156014</name>
      <address>
        <city>Guangdong</city>
        <zip>515041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156027</name>
      <address>
        <city>Guangdong</city>
        <zip>518035</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156025</name>
      <address>
        <city>Guangzhou</city>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156018</name>
      <address>
        <city>Guiyang</city>
        <zip>550002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156003</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156005</name>
      <address>
        <city>Nanjing</city>
        <zip>156005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156008</name>
      <address>
        <city>Nanjing</city>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156007</name>
      <address>
        <city>Nanjing</city>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156013</name>
      <address>
        <city>Ningbo</city>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156028</name>
      <address>
        <city>Shandong</city>
        <zip>276000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156017</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156016</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156020</name>
      <address>
        <city>Tianjin</city>
        <zip>300192</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156010</name>
      <address>
        <city>Xiamen</city>
        <zip>361003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 156029</name>
      <address>
        <city>Ürümqi</city>
        <zip>830054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 119103</name>
      <address>
        <city>Split</city>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 119101</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 119106</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 134801</name>
      <address>
        <city>Budapest</city>
        <zip>1204</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 134803</name>
      <address>
        <city>Nyiregyhaza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 134804</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 142803</name>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5417</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 142804</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 142801</name>
      <address>
        <city>Riga</city>
        <zip>LV-1038</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 148402</name>
      <address>
        <city>Colima</city>
        <zip>28018</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 148401</name>
      <address>
        <city>Guadalajara</city>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 160403</name>
      <address>
        <city>Cuzco</city>
        <zip>84</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 160410</name>
      <address>
        <city>Lima</city>
        <zip>29</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 160406</name>
      <address>
        <city>Lima</city>
        <zip>41</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 160404</name>
      <address>
        <city>Trujillo</city>
        <zip>TRUJ 01</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164204</name>
      <address>
        <city>Bucharest</city>
        <zip>050653</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164206</name>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164205</name>
      <address>
        <city>Bucuresti</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164201</name>
      <address>
        <city>Craiova</city>
        <zip>200642</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164307</name>
      <address>
        <city>Moscow</city>
        <zip>117593</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164301</name>
      <address>
        <city>Penza</city>
        <zip>440026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164308</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357500</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164311</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164303</name>
      <address>
        <city>Sankt Peterburg</city>
        <zip>194044</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 164302</name>
      <address>
        <city>Saratov</city>
        <zip>410054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 189001</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 189002</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 179207</name>
      <address>
        <city>Adapazarı</city>
        <zip>54100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 179203</name>
      <address>
        <city>Bornova</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 179202</name>
      <address>
        <city>Bostanci</city>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 179204</name>
      <address>
        <city>Diyarbakır</city>
        <zip>21280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 179205</name>
      <address>
        <city>Çankaya</city>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 180404</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 180408</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <zip>76014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 180402</name>
      <address>
        <city>Kharkiv</city>
        <zip>6111</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 180406</name>
      <address>
        <city>Kyiv</city>
        <zip>02125</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 180401</name>
      <address>
        <city>Luts'k</city>
        <zip>43000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 180403</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 180407</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>China</country>
    <country>Croatia</country>
    <country>Hungary</country>
    <country>Latvia</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czechia</country>
  </removed_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <disposition_first_submitted>December 8, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>December 8, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 12, 2022</disposition_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bacterial Infections</keyword>
  <keyword>Cefepime</keyword>
  <keyword>Meropenem</keyword>
  <keyword>Complicated Urinary Tract Infections</keyword>
  <keyword>Anti-Infective Agents</keyword>
  <keyword>β-Lactamase Inhibitors</keyword>
  <keyword>VNRX-5133 (taniborbactam)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Pyelonephritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meropenem</mesh_term>
    <mesh_term>Cefepime</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03840148
org study id: VNRX-5133-201
secondary id: 2018-001451-13
nct id: NCT03840148
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem
      in both eradication of bacteria and in symptomatic response in patients with cUTIs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Composite of microbiological eradication and symptomatic clinical success in the microbiological intent-to-treat (microITT) population at test of cure (TOC)
time frame: Days 19-23
description: Microbiologic eradication is defined as demonstration that any gram negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.
measure: Microbiological and symptomatic success at test of cure (TOC)
time frame: Days 19-23
description: The proportion of patients with both microbiological success and symptomatic clinical success at TOC in the extended microITT population.
measure: Clinical and microbiological success at end of treatment (EOT) and last follow-up (LFU)
time frame: 24 hours after last IV dose, Days 28-35
description: The proportion of patients with both microbiological success and symptomatic clinical success at EOT and LFU.
measure: Per-patient microbiological success at EOT, TOC and LFU
time frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
description: The proportion of patients with per-patient microbiological success at EOT, TOC and LFU.
measure: Patients with symptomatic clinical success at EOT, TOC and LFU
time frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
description: The proportion of patients with symptomatic clinical success at EOT, TOC and LFU.
measure: Investigator opinion of clinical success at TOC
time frame: Days 19-23
description: The proportion of patients with clinical success based on investigator opinion at TOC.
measure: Per-pathogen microbiological success at EOT, TOC and LFU
time frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
description: The proportion of patients with per-pathogen microbiological success at EOT, TOC and LFU.
measure: Microbiological and clinical success in cefepime-resistant pathogens at EOT, TOC and LFU
time frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
description: The proportion of patients with both microbiological success and symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
measure: Per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
time frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
description: The proportion of patients with per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
measure: Per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
time frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
description: The proportion of patients with per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
measure: Symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU cefepime-resistant pathogens
time frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
description: The proportion of patients with symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
measure: Number of participants with adverse events
time frame: Days 35
description: Percent of participants experiencing adverse events.
measure: Number of participants with serious adverse events
time frame: Days 35
description: Percent of participants experiencing serious adverse events.
arm group label: Cefepime/VNRX-5133 (taniborbactam)
arm group type: Experimental
description: Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
arm group label: Meropenem
arm group type: Active Comparator
description: Meropenem will be administered q8h IV over 30 minutes.
intervention type: Drug
intervention name: Cefepime/VNRX-5133 (taniborbactam)
description: Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
arm group label: Cefepime/VNRX-5133 (taniborbactam)
intervention type: Drug
intervention name: Meropenem
description: Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.
arm group label: Meropenem
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Brazil
country: Bulgaria
country: China
country: Croatia
country: Hungary
country: Latvia
country: Mexico
country: Peru
country: Romania
country: Russian Federation
country: Serbia
country: Turkey
country: Ukraine
country: United States
country: Czechia
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Pyelonephritis
mesh term: Meropenem
mesh term: Cefepime