<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/NCT02247960</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB#50607</org_study_id>
    <nct_id>NCT02247960</nct_id>
  </id_info>
  <brief_title>Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy</brief_title>
  <acronym>Abx</acronym>
  <official_title>Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary&#xD;
      catheter removal decreases the number of symptomatic urinary tract infections in patients&#xD;
      after radical prostatectomy. In addition, the investigators aim to determine whether&#xD;
      antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from&#xD;
      antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The&#xD;
      investigators also aim to identify specific populations that may be at higher risk of&#xD;
      developing urinary tract infections with urinary catheter use after radical prostatectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim analysis determined that the study should be concluded for futility.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</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>Number of Participants With a Positive Urinary Tract Infection</measure>
    <time_frame>12 months</time_frame>
    <description>After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Positive for Clostridium Difficile</measure>
    <time_frame>3 months</time_frame>
    <description>Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bacteria in Urine</measure>
    <time_frame>3 months</time_frame>
    <description>Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Urinary Tract Infection</condition>
  <condition>Clostridium Difficile</condition>
  <arm_group>
    <arm_group_label>Ciprofloxacin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Antibiotic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Antibiotic</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Antibiotic</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciprofloxacin</intervention_name>
    <arm_group_label>Ciprofloxacin</arm_group_label>
    <other_name>Cipro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects will include patients undergoing radical prostatectomy for prostate cancer.&#xD;
             Subjects will be randomized into control or treatment group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone&#xD;
             will be excluded. Subjects being treated with tizanidine or with a history of&#xD;
             myasthenia gravis will be excluded. In addition, we will exclude patients with major&#xD;
             immediate post-operative complications after prostatectomy including significant&#xD;
             post-operative bleeding with known pelvic hematoma and known urine leak.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean V Joseph, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>January 25, 2017</results_first_submitted>
  <results_first_submitted_qc>January 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2017</results_first_posted>
  <last_update_submitted>March 17, 2017</last_update_submitted>
  <last_update_submitted_qc>March 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Jean Joseph</investigator_full_name>
    <investigator_title>Professor of Urology and Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciprofloxacin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ciprofloxacin</title>
          <description>Antibiotic&#xD;
Ciprofloxacin</description>
        </group>
        <group group_id="P2">
          <title>No Antibiotic</title>
          <description>No Antibiotic</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Patient Consent and Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Catheter Removed</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were only collected on patients who had their catheter removed (ie. started period 2).</population>
      <group_list>
        <group group_id="B1">
          <title>Ciprofloxacin</title>
          <description>Antibiotic&#xD;
Ciprofloxacin</description>
        </group>
        <group group_id="B2">
          <title>No Antibiotic</title>
          <description>No Antibiotic</description>
        </group>
        <group group_id="B3">
          <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="83"/>
            <count group_id="B2" value="84"/>
            <count group_id="B3" value="167"/>
          </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="62.49" spread="6.86"/>
                    <measurement group_id="B2" value="62.98" spread="6.82"/>
                    <measurement group_id="B3" value="62.8" spread="6.8"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Positive Urinary Tract Infection</title>
        <description>After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.</description>
        <time_frame>12 months</time_frame>
        <population>this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)</population>
        <group_list>
          <group group_id="O1">
            <title>Ciprofloxacin</title>
            <description>Antibiotic&#xD;
Ciprofloxacin</description>
          </group>
          <group group_id="O2">
            <title>No Antibiotic</title>
            <description>No Antibiotic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Positive Urinary Tract Infection</title>
          <description>After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.</description>
          <population>this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)</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="83"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Positive for Clostridium Difficile</title>
        <description>Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).</description>
        <time_frame>3 months</time_frame>
        <population>this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)</population>
        <group_list>
          <group group_id="O1">
            <title>Ciprofloxacin</title>
            <description>Antibiotic&#xD;
Ciprofloxacin</description>
          </group>
          <group group_id="O2">
            <title>No Antibiotic</title>
            <description>No Antibiotic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Positive for Clostridium Difficile</title>
          <description>Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).</description>
          <population>this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)</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="83"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bacteria in Urine</title>
        <description>Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.</description>
        <time_frame>3 months</time_frame>
        <population>10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing.</population>
        <group_list>
          <group group_id="O1">
            <title>Ciprofloxacin</title>
            <description>Antibiotic&#xD;
Ciprofloxacin</description>
          </group>
          <group group_id="O2">
            <title>No Antibiotic</title>
            <description>No Antibiotic</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bacteria in Urine</title>
          <description>Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.</description>
          <population>10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing.</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="73"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events were only collected on patients who had their catheter removed (ie. started period 2).</desc>
      <group_list>
        <group group_id="E1">
          <title>Ciprofloxacin</title>
          <description>Antibiotic&#xD;
Ciprofloxacin</description>
        </group>
        <group group_id="E2">
          <title>No Antibiotic</title>
          <description>No Antibiotic</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jean Joseph</name_or_title>
      <organization>University of Rochester</organization>
      <phone>585-341-7795</phone>
      <email>jean_joseph@urmc.rochester.edu</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/NCT02247960
org study id: RSRB#50607
nct id: NCT02247960
lead sponsor: 
has dmc: Yes
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary
      catheter removal decreases the number of symptomatic urinary tract infections in patients
      after radical prostatectomy. In addition, the investigators aim to determine whether
      antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from
      antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The
      investigators also aim to identify specific populations that may be at higher risk of
      developing urinary tract infections with urinary catheter use after radical prostatectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With a Positive Urinary Tract Infection
time frame: 12 months
description: After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.
measure: Number of Participants Positive for Clostridium Difficile
time frame: 3 months
description: Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).
measure: Number of Participants With Bacteria in Urine
time frame: 3 months
description: Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.
arm group label: Ciprofloxacin
arm group type: Active Comparator
description: Antibiotic
arm group label: No Antibiotic
arm group type: No Intervention
description: No Antibiotic
intervention type: Drug
intervention name: Ciprofloxacin
arm group label: Ciprofloxacin
other name: Cipro
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean V Joseph, M.D.
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Jean Joseph
investigator title: Professor of Urology and Oncology
mesh term: Urinary Tract Infections
mesh term: Ciprofloxacin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 