<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/NCT04505683</url>
  </required_header>
  <id_info>
    <org_study_id>5081-II-2001</org_study_id>
    <nct_id>NCT04505683</nct_id>
  </id_info>
  <brief_title>A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Positive-control, Multicenter, Prospective Study to Assess Efficacy and Safety of Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sihuan Pharmaceutical Holdings Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sihuan Pharmaceutical Holdings Group Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated&#xD;
      Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">May 8, 2020</completion_date>
  <primary_completion_date type="Actual">May 8, 2020</primary_completion_date>
  <phase>Phase 2/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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with clinical cure at test-of-cure (TOC) visit</measure>
    <time_frame>Day 7 +/- 1 days after the end of treatment</time_frame>
    <description>Clinical cure is defined as complete resolution of signs,symptoms and related laboratory tests of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Complicated Urinary Tract Infection Including Acute Pyelonephritis</condition>
  <arm_group>
    <arm_group_label>test drug arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Benapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ertapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Benapenem</intervention_name>
    <description>Benapenem for IV injection administered as a 1-gram IV infusion</description>
    <arm_group_label>test drug arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ertapenem</intervention_name>
    <description>Ertapenem for IV injection administered as a 1-gram IV infusion</description>
    <arm_group_label>active control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects aged 18-75 years&#xD;
&#xD;
          2. Have a diagnosis of cUTI or AP as defined below:&#xD;
&#xD;
               1. cUTI definition:&#xD;
&#xD;
                    -  At least Two of the following signs and symptoms:&#xD;
&#xD;
                         -  Chills, rigors, or fever; fever must be observed and documented by a&#xD;
                            health care provider (tympanic temperature ≥37.3°C)&#xD;
&#xD;
                         -  Flank pain or Lower abdominal pain&#xD;
&#xD;
                         -  Dysuria, urgency to void, or increased urinary frequency&#xD;
&#xD;
                         -  Nausea or vomiting&#xD;
&#xD;
                         -  Costovertebral angle tenderness or renal percussive pain on physical&#xD;
                            examination.&#xD;
&#xD;
                         -  Blood leukocytes above upper limit of normal value&#xD;
&#xD;
                  And at least One of the following risk factors for cUTI:&#xD;
&#xD;
                    -  Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric&#xD;
                       stents), ongoing intermittent bladder catheterization, or presence of an&#xD;
                       indwelling bladder catheter (Note: bladder catheters prior to Screening&#xD;
                       should be expected to remove during study period&#xD;
&#xD;
                    -  post-void residual urine volume of ≥ 100 mL;&#xD;
&#xD;
                    -  Obstructive uropathy (e.g. bladder outlet obstruction, nephrolithiasis,&#xD;
                       prostatic hyperplasia) that is expected to be removed during study drug&#xD;
                       therapy;&#xD;
&#xD;
                    -  Perioperative urinary tract infection.&#xD;
&#xD;
               2. AP definition: And at least One of the following signs and symptoms:&#xD;
&#xD;
                    -  Chills, rigors, or fever; fever must be observed and documented by a health&#xD;
                       care provider (tympanic temperature ≥37.3°C）；&#xD;
&#xD;
                    -  Flank pain&#xD;
&#xD;
                    -  Dysuria, urgency to void, or increased urinary frequency&#xD;
&#xD;
                    -  Nausea or vomiting&#xD;
&#xD;
                    -  Costovertebral angle tenderness or renal percussive pain on physical&#xD;
                       examination.&#xD;
&#xD;
                    -  Blood leukocytes above upper limit of normal value&#xD;
&#xD;
          3. Patients or legal representatives can be able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receipt of potentially effective antibiotic therapy more than 24h within 72 h prior to&#xD;
             randomization&#xD;
&#xD;
          2. Anticipated concomitant use of other systemic antibiotic drugs during the study period&#xD;
&#xD;
          3. Anticipated continnue to preventive anti-infectious therapy after cUTI patients&#xD;
             completed investigational drug treatment&#xD;
&#xD;
          4. Presence of any known or suspected disease or condition as following:&#xD;
&#xD;
               -  Uncomplicated urinary tract infection (uUTI)&#xD;
&#xD;
               -  Fungal Urinary tract infection&#xD;
&#xD;
               -  Perinephric or renal corticomedullary abscess&#xD;
&#xD;
               -  Polycystic kidney disease&#xD;
&#xD;
               -  Urinary tuberculosis&#xD;
&#xD;
               -  Obstructive uropathy(e.g.congenital malformation) unable to remove during&#xD;
                  treatment.&#xD;
&#xD;
               -  Ideal loop surgery or vesicoureteral reflux&#xD;
&#xD;
               -  Permannent bladder catheterization or long term indwelling nephrostomy tube&#xD;
&#xD;
               -  Previous or planned renal transplantation&#xD;
&#xD;
               -  Patients undergoing dialysis&quot;&#xD;
&#xD;
          5. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or&#xD;
             epididymitis&#xD;
&#xD;
          6. Confirmed or suspected sexually transmitted disease,e.g. gonorrhea and syphilis&#xD;
&#xD;
          7. Confirmed or suspected non-renal source of infection (e.g., infective endocarditis,&#xD;
             osteomyelitis, meningitis, pneumonia)&#xD;
&#xD;
          8. Trauma to the pelvis or urinary tract within 7days before enrollment&#xD;
&#xD;
          9. Rapid onset or life-threatening diseases, such as septic shock, respiratory failure,&#xD;
             sepsis, etc;&#xD;
&#xD;
         10. Severe cardiovascular and cerebrovascular diseases, acute myocardial infarction, acute&#xD;
             ischemic stroke, acute Hemorrhagic stroke or intravascular intervention within&#xD;
             recently 3 months&#xD;
&#xD;
         11. Known or suspected central nerve system disorders, prone to epilepsy(e.g severe&#xD;
             carebral arteriosclerosis)&#xD;
&#xD;
         12. Known history of immunodeficiency diease, e.g.AIDS or human immunodeficiency virus&#xD;
             (HIV) infection,hematologic malignancy, bone marrow transplant, or receiving&#xD;
             immunosuppressive therapy such as cancer chemotherapy, medications for the rejection&#xD;
             of transplantation, and long term use of systemic corticosteroids;&#xD;
&#xD;
         13. Use of valproic acid or probenecid within 30 days before enrollment or during study&#xD;
             period.&#xD;
&#xD;
         14. Hepatic impairment at Screening, evidenced as:&#xD;
&#xD;
               -  alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;3x upper&#xD;
                  limit of normal (ULN);&#xD;
&#xD;
               -  total bilirubin &gt;1.5x ULN;&#xD;
&#xD;
               -  alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;2x upper&#xD;
                  limit of normal (ULN) and total bilirubin &gt; ULN; Creatinine clearance (CrCl) of&#xD;
                  &lt;60 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine&#xD;
                  Clearance (eC_Cr) [mL/min]=((140-Age [yrs]) × Body Weight [kg] × [0.85 if&#xD;
                  Female])/(72 × Serum Creatinine [mg⁄dL])&#xD;
&#xD;
         15. Known allergic to β-lactam drugs or in an allergic state&#xD;
&#xD;
         16. Confirmed or suspected alcohol or drug abuse history&#xD;
&#xD;
         17. Patients with other mental disorders who are unable or unwilling to cooperate.&#xD;
&#xD;
         18. Pregnant or breastfeeding women or plan to pregnant and unwilling to take&#xD;
             contraceptive methods&#xD;
&#xD;
         19. Participants in other clinical trials within 3 months before enrollment.&#xD;
&#xD;
         20. Other situations that the investigators considers not suitable to participate in this&#xD;
             clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 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>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>Ertapenem</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04505683
org study id: 5081-II-2001
nct id: NCT04505683
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated
      Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of patients with clinical cure at test-of-cure (TOC) visit
time frame: Day 7 +/- 1 days after the end of treatment
description: Clinical cure is defined as complete resolution of signs,symptoms and related laboratory tests of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
arm group label: test drug arm
arm group type: Experimental
description: Benapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.
arm group label: active control arm
arm group type: Active Comparator
description: Ertapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.
intervention type: Drug
intervention name: Benapenem
description: Benapenem for IV injection administered as a 1-gram IV infusion
arm group label: test drug arm
intervention type: Drug
intervention name: Ertapenem
description: Ertapenem for IV injection administered as a 1-gram IV infusion
arm group label: active control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Pyelonephritis
mesh term: Ertapenem