<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/NCT04502095</url>
  </required_header>
  <id_info>
    <org_study_id>I 573720</org_study_id>
    <secondary_id>NCI-2020-04928</secondary_id>
    <secondary_id>I 573720</secondary_id>
    <nct_id>NCT04502095</nct_id>
  </id_info>
  <brief_title>Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy</brief_title>
  <official_title>Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial investigates whether a one-month course of preventative (prophylactic) antibiotics&#xD;
      helps to reduce urinary tract infections after robot-assisted surgery to remove all of the&#xD;
      bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections&#xD;
      are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as&#xD;
      trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients&#xD;
      with urinary tract infection and may help improve their response to radical cystectomy.&#xD;
      Information gained from this study may help researchers to predict patient complications and&#xD;
      identify better ways to manage these complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine if the utilization of a prophylactic antibiotic during the postoperative&#xD;
      period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical&#xD;
      cystectomy.&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
      I. To identify pre- and post-operative factors that may be associated with the development of&#xD;
      a 90-day UTI following radical cystectomy.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I (ANTIBIOTIC): Patients receive ertapenem orally (PO), levofloxacin PO, or clindamycin&#xD;
      PO induction therapy per standard of care. At the time of full diet, patients receive&#xD;
      trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients&#xD;
      complete a drug diary for each day they receive the antibiotic.&#xD;
&#xD;
      GROUP II (CONTROL): Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO&#xD;
      induction therapy per standard of care.&#xD;
&#xD;
      After surgery, patients are followed up to 120 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Anticipated">September 2, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2, 2024</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>90-day urinary tract infection (UTI) status</measure>
    <time_frame>At 90 days after surgery</time_frame>
    <description>Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identify pre-operative factors associated with the development of UTI</measure>
    <time_frame>Up to 120 days after surgery</time_frame>
    <description>stratified logistic regression models (stratified by antibiotic use)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of Clostridium difficile (C Diff)</measure>
    <time_frame>up to 120 days after surgery</time_frame>
    <description>Will be evaluated in patients who received prophylactic antibiotics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infections occurring during antibiotic use</measure>
    <time_frame>Up to 120 days after surgery</time_frame>
    <description>To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify post operative factors associated with the development of UTI</measure>
    <time_frame>Up to 120 days after surgery</time_frame>
    <description>stratified logistic regression models (stratified by antibiotic use)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Bladder Carcinoma</condition>
  <condition>Refractory Bladder Carcinoma</condition>
  <condition>Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (standard of care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clindamycin</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)</arm_group_label>
    <arm_group_label>Group II (standard of care)</arm_group_label>
    <other_name>Cleocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diary</intervention_name>
    <description>Complete drug diary</description>
    <arm_group_label>Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ertapenem</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)</arm_group_label>
    <arm_group_label>Group II (standard of care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)</arm_group_label>
    <arm_group_label>Group II (standard of care)</arm_group_label>
    <other_name>(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hydrate (2:1)</other_name>
    <other_name>Levaquin</other_name>
    <other_name>Levofloxacin Hydrate</other_name>
    <other_name>Quixin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrofurantoin</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)</arm_group_label>
    <other_name>Macrobid</other_name>
    <other_name>Macrodantin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimethoprim-Sulfamethoxazole</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)</arm_group_label>
    <other_name>Bactrim</other_name>
    <other_name>Bactrim DS</other_name>
    <other_name>Bactrimel</other_name>
    <other_name>Centran</other_name>
    <other_name>Centrin</other_name>
    <other_name>Co-Trimoxazole</other_name>
    <other_name>Cotrim</other_name>
    <other_name>Cotrimoxazole</other_name>
    <other_name>Eslectin</other_name>
    <other_name>Insozalin</other_name>
    <other_name>Septra</other_name>
    <other_name>SMZ-TMP</other_name>
    <other_name>Sulfamethoprim</other_name>
    <other_name>Sulfatrim</other_name>
    <other_name>Sulmeprim</other_name>
    <other_name>TMP-SMX</other_name>
    <other_name>Trimedin</other_name>
    <other_name>Trimezole</other_name>
    <other_name>Uroplus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient that electively chooses to have a cystectomy is eligible to participate in&#xD;
             the study. Indications for a person who may undergo a cystectomy include having a&#xD;
             diagnosis of muscle-invasive bladder cancer (MIBC) or refractory non-muscle invasive&#xD;
             bladder cancer (NMIBC)&#xD;
&#xD;
          -  Any patient that will electively choose to have a robot-assisted radical cystectomy&#xD;
             and is able to provide consent&#xD;
&#xD;
          -  Participant or legal representative must understand the investigational nature of this&#xD;
             study and sign an Independent Ethics Committee/Institutional Review Board approved&#xD;
             written informed consent form prior to receiving any study related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of myasthenia gravis&#xD;
&#xD;
          -  Patients with a history of QT prolongation or taking other drugs that prolong&#xD;
             corrected QTc (QTc) should be excluded&#xD;
&#xD;
          -  Patients with renal dysfunction, creatinine clearance (mL/min) &lt; 30&#xD;
&#xD;
          -  Pregnant or nursing female participants&#xD;
&#xD;
          -  Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements&#xD;
&#xD;
          -  Patients who receive a prophylactic antibiotic or antibiotic for any other reason&#xD;
             prior to discharge&#xD;
&#xD;
          -  Any condition which in the investigator's opinion deems the participant an unsuitable&#xD;
             candidate to receive study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khurshid A Guru</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Khurshid A. Guru</last_name>
      <phone>716-845-4107</phone>
      <email>Khurshid.Guru@roswellpark.org</email>
    </contact>
    <investigator>
      <last_name>Khurshid A. Guru</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</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>Carcinoma</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levofloxacin</mesh_term>
    <mesh_term>Ofloxacin</mesh_term>
    <mesh_term>Trimethoprim</mesh_term>
    <mesh_term>Trimethoprim, Sulfamethoxazole Drug Combination</mesh_term>
    <mesh_term>Nitrofurantoin</mesh_term>
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Ertapenem</mesh_term>
    <mesh_term>Sulfamethoxazole</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/NCT04502095
org study id: I 573720
secondary id: NCI-2020-04928
secondary id: I 573720
nct id: NCT04502095
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This trial investigates whether a one-month course of preventative (prophylactic) antibiotics
      helps to reduce urinary tract infections after robot-assisted surgery to remove all of the
      bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections
      are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as
      trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients
      with urinary tract infection and may help improve their response to radical cystectomy.
      Information gained from this study may help researchers to predict patient complications and
      identify better ways to manage these complications.
PRIMARY OBJECTIVE:

      I. To determine if the utilization of a prophylactic antibiotic during the postoperative
      period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical
      cystectomy.

      SECONDARY OBJECTIVE:

      I. To identify pre- and post-operative factors that may be associated with the development of
      a 90-day UTI following radical cystectomy.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I (ANTIBIOTIC): Patients receive ertapenem orally (PO), levofloxacin PO, or clindamycin
      PO induction therapy per standard of care. At the time of full diet, patients receive
      trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients
      complete a drug diary for each day they receive the antibiotic.

      GROUP II (CONTROL): Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO
      induction therapy per standard of care.

      After surgery, patients are followed up to 120 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 90-day urinary tract infection (UTI) status
time frame: At 90 days after surgery
description: Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.
measure: Identify pre-operative factors associated with the development of UTI
time frame: Up to 120 days after surgery
description: stratified logistic regression models (stratified by antibiotic use)
measure: Development of Clostridium difficile (C Diff)
time frame: up to 120 days after surgery
description: Will be evaluated in patients who received prophylactic antibiotics.
measure: Infections occurring during antibiotic use
time frame: Up to 120 days after surgery
description: To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.
measure: Identify post operative factors associated with the development of UTI
time frame: Up to 120 days after surgery
description: stratified logistic regression models (stratified by antibiotic use)
arm group label: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
arm group type: Experimental
description: Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.
arm group label: Group II (standard of care)
arm group type: Active Comparator
description: Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
intervention type: Drug
intervention name: Clindamycin
description: Given PO
arm group label: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
arm group label: Group II (standard of care)
other name: Cleocin
intervention type: Other
intervention name: Diary
description: Complete drug diary
arm group label: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
intervention type: Drug
intervention name: Ertapenem
description: Given PO
arm group label: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
arm group label: Group II (standard of care)
intervention type: Drug
intervention name: Levofloxacin
description: Given PO
arm group label: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
arm group label: Group II (standard of care)
other name: (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hydrate (2:1)
other name: Levaquin
other name: Levofloxacin Hydrate
other name: Quixin
intervention type: Drug
intervention name: Nitrofurantoin
description: Given PO
arm group label: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
other name: Macrobid
other name: Macrodantin
intervention type: Drug
intervention name: Trimethoprim-Sulfamethoxazole
description: Given PO
arm group label: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
other name: Bactrim
other name: Bactrim DS
other name: Bactrimel
other name: Centran
other name: Centrin
other name: Co-Trimoxazole
other name: Cotrim
other name: Cotrimoxazole
other name: Eslectin
other name: Insozalin
other name: Septra
other name: SMZ-TMP
other name: Sulfamethoprim
other name: Sulfatrim
other name: Sulmeprim
other name: TMP-SMX
other name: Trimedin
other name: Trimezole
other name: Uroplus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Khurshid A Guru
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Carcinoma
mesh term: Urinary Bladder Neoplasms
mesh term: Levofloxacin
mesh term: Ofloxacin
mesh term: Trimethoprim
mesh term: Trimethoprim, Sulfamethoxazole Drug Combination
mesh term: Nitrofurantoin
mesh term: Clindamycin
mesh term: Ertapenem
mesh term: Sulfamethoxazole