xml: <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/NCT06007352</url>
    </required_header>
    <id_info>
      <org_study_id>2000035721</org_study_id>
      <nct_id>NCT06007352</nct_id>
    </id_info>
    <brief_title>Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis</brief_title>
    <official_title>Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yale University</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to investigate whether the use of gentamicin-based irrigation&#xD;
        fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections&#xD;
        after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective of this study is to determine whether the utilization of&#xD;
        gentamicin-based irrigation fluid during ureteroscopy decreases the rate of 30-day&#xD;
        post-operative symptomatic urinary tract infections in patients at higher risk of urinary&#xD;
        tract infection undergoing stone surgery for urolithiasis.&#xD;
  &#xD;
        The secondary objectives of this study are to determine whether the utilization of&#xD;
        gentamicin-based irrigation fluid during ureteroscopy affects the 30-day post-operative rates&#xD;
        of patient-initiated telephone calls, readmission rates, urosepsis rates based on SIRS&#xD;
        criteria, and overall post-operative oral/intravenous antibiotic administration.&#xD;
  &#xD;
        In this prospective study, 120 mg of gentamicin prepared in 3 liters of normal saline will be&#xD;
        used as irrigation during ureteroscopic surgery for urolithiasis. At this concentration, 40&#xD;
        μg/mL, the MBC would be achieved for pathogenic urogenital bacteria. Due to the concerns of&#xD;
        nephrotoxicity and ototoxicity at higher doses of gentamicin, in the unlikely event of&#xD;
        complete pyelo-venous backflow, the intravenous circulation of 120 mg of gentamicin would be&#xD;
        less than the surgical prophylaxis intravenous dosing for patients weighing more than 60 kg.&#xD;
        For the single intravenous dose for surgical prophylaxis, post-operative monitoring of renal&#xD;
        function, and gentamicin peak and trough levels are not routinely obtained.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</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>
      <intervention_model_description>phase II, parallel randomized control trial with 1:1 allocation</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Symptomatic urinary tract infection</measure>
      <time_frame>Within 30 days of surgery</time_frame>
      <description>Development of a symptomatic urinary tract infection after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Urosepsis</measure>
      <time_frame>Within 30 days of surgery</time_frame>
      <description>Development of urosepsis after URS based on SIRS criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-admission to hospital</measure>
      <time_frame>Within 30 days of surgery</time_frame>
      <description>Re-admission to hospital after surgery for any reason</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient self-reported symptoms</measure>
      <time_frame>within 30 days of surgery</time_frame>
      <description>Self-reported symptoms after the operation of the following: new hearing loss, vertigo and dizziness</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">412</enrollment>
    <condition>Urinary Tract Infections</condition>
    <condition>Sepsis</condition>
    <arm_group>
      <arm_group_label>Gentamicin-Based Irrigation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3 L NaCl Irrigation</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>This group will receive the typical NaCl irrigation used during ureteroscopy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gentamicin</intervention_name>
      <description>Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy</description>
      <arm_group_label>Gentamicin-Based Irrigation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>3 L of NaCl irrigation typically used for ureteroscopy surgery</description>
      <arm_group_label>3 L NaCl Irrigation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal&#xD;
               stones) warranting surgical intervention in line with American Urological Association&#xD;
               guidelines for urolithiasis&#xD;
  &#xD;
            -  At a higher risk for infectious complications following ureteroscopy based on a&#xD;
               history of atleast one of the below:&#xD;
  &#xD;
            -  3 more urinary tract infections over 12 month period not on suppressive antibiotic&#xD;
               therapy&#xD;
  &#xD;
            -  Prior infectious complication following ureteroscopy&#xD;
  &#xD;
            -  Placement of ureteral stent in the setting of obstructing ureteral stone with concern&#xD;
               for superimposed urinary tract infection&#xD;
  &#xD;
            -  Positive pre-operative urine culture treated with culture-appropriate antimicrobial&#xD;
               therapy&#xD;
  &#xD;
            -  Planned for cystoscopy, ureteroscopy with possible laser lithotripsy, and ureteral&#xD;
               stent placement&#xD;
  &#xD;
            -  For females of reproductive potential: use of highly effective contraception for at&#xD;
               least 1 month prior to screening and agreement to use such a method during study&#xD;
               participation and for an additional 8 weeks after the end of gentamicin&#xD;
               administration. Female patients of reproductive potential will have pregnancy screen&#xD;
               prior to surgery per standard operating room protocol.&#xD;
  &#xD;
            -  For males of reproductive potential: use of condoms or other methods to ensure&#xD;
               effective contraception with partner&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Estimated Glomerular Filtration Rate less than 60 mL/min&#xD;
  &#xD;
            -  History of sensorineural hearing loss, vertigo, idiopathic dizziness&#xD;
  &#xD;
            -  Active pregnancy or currently lactating&#xD;
  &#xD;
            -  Known allergic reactions to components of gentamicin&#xD;
  &#xD;
            -  Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Piruz Motamedinia, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale School of Medicine, Department of Urology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Piruz Motamedinia, M.D.</last_name>
      <phone>203-785-2815</phone>
      <email>piruz.motamedinia@yale.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ankur Choksi, M.D.</last_name>
      <email>ankur.choksi@yale.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Yale New Haven Health</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06510</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Piruz Motamedinia, M.D.</last_name>
        <email>piruz.motamedinia@yale.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>UTI</keyword>
    <keyword>Gentamicin</keyword>
    <keyword>Ureteroscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Tract Infections</mesh_term>
      <mesh_term>Urolithiasis</mesh_term>
      <mesh_term>Urinary Calculi</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gentamicins</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007352
  org study id: 2000035721
  nct id: NCT06007352
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of the study is to investigate whether the use of gentamicin-based irrigation
        fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections
        after surgery.
  The primary objective of this study is to determine whether the utilization of
        gentamicin-based irrigation fluid during ureteroscopy decreases the rate of 30-day
        post-operative symptomatic urinary tract infections in patients at higher risk of urinary
        tract infection undergoing stone surgery for urolithiasis.
  
        The secondary objectives of this study are to determine whether the utilization of
        gentamicin-based irrigation fluid during ureteroscopy affects the 30-day post-operative rates
        of patient-initiated telephone calls, readmission rates, urosepsis rates based on SIRS
        criteria, and overall post-operative oral/intravenous antibiotic administration.
  
        In this prospective study, 120 mg of gentamicin prepared in 3 liters of normal saline will be
        used as irrigation during ureteroscopic surgery for urolithiasis. At this concentration, 40
        μg/mL, the MBC would be achieved for pathogenic urogenital bacteria. Due to the concerns of
        nephrotoxicity and ototoxicity at higher doses of gentamicin, in the unlikely event of
        complete pyelo-venous backflow, the intravenous circulation of 120 mg of gentamicin would be
        less than the surgical prophylaxis intravenous dosing for patients weighing more than 60 kg.
        For the single intravenous dose for surgical prophylaxis, post-operative monitoring of renal
        function, and gentamicin peak and trough levels are not routinely obtained.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: phase II, parallel randomized control trial with 1:1 allocation
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Symptomatic urinary tract infection
  time frame: Within 30 days of surgery
  description: Development of a symptomatic urinary tract infection after surgery
  measure: Urosepsis
  time frame: Within 30 days of surgery
  description: Development of urosepsis after URS based on SIRS criteria
  measure: Re-admission to hospital
  time frame: Within 30 days of surgery
  description: Re-admission to hospital after surgery for any reason
  measure: Patient self-reported symptoms
  time frame: within 30 days of surgery
  description: Self-reported symptoms after the operation of the following: new hearing loss, vertigo and dizziness
  arm group label: Gentamicin-Based Irrigation
  arm group type: Experimental
  description: This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy
  arm group label: 3 L NaCl Irrigation
  arm group type: Placebo Comparator
  description: This group will receive the typical NaCl irrigation used during ureteroscopy
  intervention type: Drug
  intervention name: Gentamicin
  description: Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy
  arm group label: Gentamicin-Based Irrigation
  intervention type: Other
  intervention name: Placebo
  description: 3 L of NaCl irrigation typically used for ureteroscopy surgery
  arm group label: 3 L NaCl Irrigation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Piruz Motamedinia, M.D.
  role: Principal Investigator
  affiliation: Yale School of Medicine, Department of Urology
  last name: Piruz Motamedinia, M.D.
  phone: 203-785-2815
  email: piruz.motamedinia@yale.edu
  last name: Ankur Choksi, M.D.
  email: ankur.choksi@yale.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Urinary Tract Infections
  mesh term: Urolithiasis
  mesh term: Urinary Calculi
  mesh term: Gentamicins
  sharing ipd: No