<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/NCT01691430</url>
  </required_header>
  <id_info>
    <org_study_id>1112009472</org_study_id>
    <secondary_id>2P30AG021342-11</secondary_id>
    <secondary_id>1R01AG041153-01A1</secondary_id>
    <nct_id>NCT01691430</nct_id>
  </id_info>
  <brief_title>A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents</brief_title>
  <official_title>A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urinary tract infection (UTI) is the most common infection in nursing home residents, and&#xD;
      bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting.&#xD;
      The primary aim of this study is to test the efficacy of two oral cranberry capsules per day&#xD;
      in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will&#xD;
      be accomplished by conducting a double blind randomized placebo controlled efficacy trial of&#xD;
      two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing&#xD;
      home residents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>
    <intervention_model_description>Participants were randomized to cranberry or placebo capsules.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants With Urine Cultures With Bacteriuria (&gt;100,000 Cfu/ml or &gt;=100,000 Cfu/ml) Plus Pyuria (Any WBC)</measure>
    <time_frame>One year</time_frame>
    <description>Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Episodes of Symptomatic UTI</measure>
    <time_frame>One year</time_frame>
    <description>Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospitalizations</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Deaths</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Antibiotic Prescriptions</measure>
    <time_frame>One year</time_frame>
    <description>Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacteriuria With Multidrug-resistant Gram-negative Bacilli</measure>
    <time_frame>One year</time_frame>
    <description>All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Antibiotic Prescriptions for Suspected UTI</measure>
    <time_frame>One Year</time_frame>
    <description>Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjects With 1, 2, or 3 Episodes of UTIs</measure>
    <time_frame>One year</time_frame>
    <description>Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Adverse Events in Participants</measure>
    <time_frame>One year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to Capsule Intake by All Participants</measure>
    <time_frame>One year</time_frame>
    <description>measured by capsules removed from blister packs</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>Bacteriuria</condition>
  <arm_group>
    <arm_group_label>2 cranberry capsules</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Experimental: 2 cranberry capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 placebo capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Experimental: 2 placebo capsules qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>2 cranberry capsules</intervention_name>
    <description>Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
    <arm_group_label>2 cranberry capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
    <arm_group_label>2 placebo capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. female residents;&#xD;
&#xD;
          2. long term residents&#xD;
&#xD;
          3. English speaking; and&#xD;
&#xD;
          4. age ≥ 65 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. residents that are not expected to be in the nursing home for at least one month&#xD;
             (i.e., short term rehabilitation, pending discharge, terminal [life expectancy &lt; 1&#xD;
             month]);&#xD;
&#xD;
          2. residents who are on chronic suppressive antibiotic or anti-infective (i.e.,&#xD;
             mandelamine) therapy for recurrent UTI;&#xD;
&#xD;
          3. residents with end stage renal disease on dialysis (they do not regularly produce&#xD;
             urine);&#xD;
&#xD;
          4. residents unable to produce a baseline clean catch urine specimen for collection;&#xD;
&#xD;
          5. residents on warfarin therapy because of a potential interaction of warfarin and&#xD;
             cranberry juice;&#xD;
&#xD;
          6. residents with a history of nephrolithiasis because cranberry may increase the risk of&#xD;
             nephrolithiasis;&#xD;
&#xD;
          7. have an indwelling bladder catheter in place;&#xD;
&#xD;
          8. have an allergy to cranberry products;&#xD;
&#xD;
          9. are being treated with cranberry products;&#xD;
&#xD;
         10. residence &lt;4 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manisha Juthani-Mehta, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Branford Hills Health Care</name>
      <address>
        <city>Branford</city>
        <state>Connecticut</state>
        <zip>06405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northbridge Health Care Center</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bridgeport Health Care Center</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bridgeport Manor</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Health &amp; Rehabilitation Center</name>
      <address>
        <city>East Hartford</city>
        <state>Connecticut</state>
        <zip>06108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludlowe Health Care Center</name>
      <address>
        <city>Fairfield</city>
        <state>Connecticut</state>
        <zip>06825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glastonbury Health Care Center</name>
      <address>
        <city>Glastonbury</city>
        <state>Connecticut</state>
        <zip>06033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Nathaniel Witherell</name>
      <address>
        <city>Greenwich</city>
        <state>Connecticut</state>
        <zip>06830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arden House Care and Rehabilitation Center</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamden Health Care Center</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avery Heights</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wadsworth Glen Health Care and Rehabilitation Center</name>
      <address>
        <city>Middletown</city>
        <state>Connecticut</state>
        <zip>06457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Water's Edge Center for Health &amp; Rehabilitation</name>
      <address>
        <city>Middletown</city>
        <state>Connecticut</state>
        <zip>06457</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grimes Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Wade Home</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Nursing &amp; Rehab Center of New Haven</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shady Knoll Health Center</name>
      <address>
        <city>Seymour</city>
        <state>Connecticut</state>
        <zip>06483</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lord Chamberlain Nursing &amp; Rehabilitation Center</name>
      <address>
        <city>Stratford</city>
        <state>Connecticut</state>
        <zip>06614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Village Green of Wallingford</name>
      <address>
        <city>Wallingford</city>
        <state>Connecticut</state>
        <zip>06492</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Terrace Health Center</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hughes Health &amp; Rehab Center</name>
      <address>
        <city>West Hartford</city>
        <state>Connecticut</state>
        <zip>06119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>February 14, 2017</results_first_submitted>
  <results_first_submitted_qc>June 22, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 29, 2018</results_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 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>Bacteriuria</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruited from nursing homes within 50 miles of New Haven.</recruitment_details>
      <pre_assignment_details>806 patients were eligible, 558 declined to participate. Of the 248 consented, 63 were found to be ineligible after consent, leaving 185 to randomize.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>2 Cranberry Capsules</title>
          <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
        </group>
        <group group_id="P2">
          <title>2 Placebo Capsules</title>
          <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Medication</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Inclusion criteria were (1) female; (2) long-term care residents; (3) English speaking; and (4) 65 years or older.</population>
      <group_list>
        <group group_id="B1">
          <title>2 Cranberry Capsules</title>
          <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
        </group>
        <group group_id="B2">
          <title>2 Placebo Capsules</title>
          <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</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="92"/>
            <count group_id="B2" value="93"/>
            <count group_id="B3" value="185"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</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>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="185"/>
                  </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="92"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="185"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</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>
              <title>Non-White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bacteriuria plus pyuria</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participants With Urine Cultures With Bacteriuria (&gt;100,000 Cfu/ml or &gt;=100,000 Cfu/ml) Plus Pyuria (Any WBC)</title>
        <description>Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.</description>
        <time_frame>One year</time_frame>
        <population>147 subjects completed 1 year, 33 died. 20 subjects, 9 in the treatment group v 11 in the control group, became incontinent prior to the first time point, thus unable to provide any urine. 45 subjects stopped taking the capsules, 24 in treatment and 21 in control; 21 refused, 19 transitioned to hospice, 4 started warfarin, and 1 refused via family.</population>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With Urine Cultures With Bacteriuria (&gt;100,000 Cfu/ml or &gt;=100,000 Cfu/ml) Plus Pyuria (Any WBC)</title>
          <description>Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.</description>
          <population>147 subjects completed 1 year, 33 died. 20 subjects, 9 in the treatment group v 11 in the control group, became incontinent prior to the first time point, thus unable to provide any urine. 45 subjects stopped taking the capsules, 24 in treatment and 21 in control; 21 refused, 19 transitioned to hospice, 4 started warfarin, and 1 refused via family.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Episodes of Symptomatic UTI</title>
        <description>Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.</description>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Episodes of Symptomatic UTI</title>
          <description>Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.</description>
          <units>symptomatic urinary tract infections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hospitalizations</title>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hospitalizations</title>
          <units>hospitilizations</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Deaths</title>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Deaths</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Antibiotic Prescriptions</title>
        <description>Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.</description>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Antibiotic Prescriptions</title>
          <description>Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.</description>
          <units>prescriptions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1415"/>
                    <measurement group_id="O2" value="1883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bacteriuria With Multidrug-resistant Gram-negative Bacilli</title>
        <description>All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).</description>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Bacteriuria With Multidrug-resistant Gram-negative Bacilli</title>
          <description>All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).</description>
          <units>episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Antibiotic Prescriptions for Suspected UTI</title>
        <description>Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.</description>
        <time_frame>One Year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Antibiotic Prescriptions for Suspected UTI</title>
          <description>Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.</description>
          <units>prescriptions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="692"/>
                    <measurement group_id="O2" value="909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Adverse Events in Participants</title>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events in Participants</title>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious unrelated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>non-serious unrelated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1731"/>
                    <measurement group_id="O2" value="1966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>non-serious related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adherence to Capsule Intake by All Participants</title>
        <description>measured by capsules removed from blister packs</description>
        <time_frame>One year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence to Capsule Intake by All Participants</title>
          <description>measured by capsules removed from blister packs</description>
          <units>percentage of capsules</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5"/>
                    <measurement group_id="O2" value="82.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjects With 1, 2, or 3 Episodes of UTIs</title>
        <description>Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.</description>
        <time_frame>One year</time_frame>
        <population>There were 10 symptomatic UTIs in the treatment group (8 participants with 1 episode and 1 participant with 2 episodes) and 12 symptomatic UTIs in the control group (7 participants with 1 episode, 1 participant with 2 episodes, and 1 participant with 3 episodes).</population>
        <group_list>
          <group group_id="O1">
            <title>2 Cranberry Capsules</title>
            <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
          <group group_id="O2">
            <title>2 Placebo Capsules</title>
            <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects With 1, 2, or 3 Episodes of UTIs</title>
          <description>Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.</description>
          <population>There were 10 symptomatic UTIs in the treatment group (8 participants with 1 episode and 1 participant with 2 episodes) and 12 symptomatic UTIs in the control group (7 participants with 1 episode, 1 participant with 2 episodes, and 1 participant with 3 episodes).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 episode</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 episodes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 episodes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>2 Cranberry Capsules</title>
          <description>Experimental: 2 cranberry capsules&#xD;
2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
        </group>
        <group group_id="E2">
          <title>2 Placebo Capsules</title>
          <description>Experimental: 2 placebo capsules qd&#xD;
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="92"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="93" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal blood glucose</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Blood pressure alteration</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>ear problem</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>eye infection</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>constipation</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>GI disturbance</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>edema</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>fever</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Generalized malaise</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>insomnia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>joint pain</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>lab abnormality</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>oral cavity disturbance</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>exposure to influenza</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>weight gain</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>weight loss</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>leg pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Altered mental status</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute chest pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>respiratory difficulty</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>skin/soft tissue event</sub_title>
                <counts group_id="E1" subjects_affected="71" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Manisha Juthani-Mehta</name_or_title>
      <organization>Yale University</organization>
      <phone>(203)785-4140</phone>
      <email>manisha.juthani@yale.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/NCT01691430
org study id: 1112009472
secondary id: 2P30AG021342-11
secondary id: 1R01AG041153-01A1
nct id: NCT01691430
lead sponsor: 
collaborator: 
has dmc: No
Urinary tract infection (UTI) is the most common infection in nursing home residents, and
      bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting.
      The primary aim of this study is to test the efficacy of two oral cranberry capsules per day
      in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will
      be accomplished by conducting a double blind randomized placebo controlled efficacy trial of
      two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing
      home residents.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized to cranberry or placebo capsules.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
time frame: One year
description: Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
measure: Number of Episodes of Symptomatic UTI
time frame: One year
description: Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.
measure: Number of Hospitalizations
time frame: One year
measure: Number of Deaths
time frame: One year
measure: Number of Antibiotic Prescriptions
time frame: One year
description: Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.
measure: Bacteriuria With Multidrug-resistant Gram-negative Bacilli
time frame: One year
description: All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).
measure: Number of Antibiotic Prescriptions for Suspected UTI
time frame: One Year
description: Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.
measure: Subjects With 1, 2, or 3 Episodes of UTIs
time frame: One year
description: Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.
measure: Number of Adverse Events in Participants
time frame: One year
measure: Adherence to Capsule Intake by All Participants
time frame: One year
description: measured by capsules removed from blister packs
arm group label: 2 cranberry capsules
arm group type: Active Comparator
description: Experimental: 2 cranberry capsules
arm group label: 2 placebo capsules
arm group type: Placebo Comparator
description: Experimental: 2 placebo capsules qd
intervention type: Dietary Supplement
intervention name: 2 cranberry capsules
description: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
arm group label: 2 cranberry capsules
intervention type: Dietary Supplement
intervention name: Placebo
description: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
arm group label: 2 placebo capsules
criteria: 
gender: Female
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manisha Juthani-Mehta, M.D.
role: Principal Investigator
affiliation: Yale School of Medicine
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country: United States
responsible party type: Sponsor
mesh term: Bacteriuria
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 