<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/NCT03299387</url>
  </required_header>
  <id_info>
    <org_study_id>11-002887</org_study_id>
    <nct_id>NCT03299387</nct_id>
  </id_info>
  <brief_title>INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI</brief_title>
  <acronym>INSTANT</acronym>
  <official_title>INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women have problems with oral antibiotics, including vagina and bowel infections. Also,&#xD;
      bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement&#xD;
      of antibiotic directly into the bladder does not cause these problems and are at doses that&#xD;
      are may be able to stop bacteria from being resistant to antibiotics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each participant once enrolled returns with an active Urinary Tract Infection (UTI),&#xD;
      confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent&#xD;
      with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin&#xD;
      treatment for 7 days, or intravesical gentamicin instillation once a day for three days.&#xD;
      Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and&#xD;
      with a repeated questionnaire for symptom relief.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study never recruited&#xD;
  </why_stopped>
  <start_date type="Actual">June 28, 2017</start_date>
  <completion_date type="Actual">July 5, 2018</completion_date>
  <primary_completion_date type="Actual">July 5, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in microbiologic effect of a chronic acute Urinary Tract Infection</measure>
    <time_frame>baseline, 7-10 days</time_frame>
    <description>Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in symptomatic relief of a chronic acute Urinary Tract Infection</measure>
    <time_frame>baseline, 7-10 days</time_frame>
    <description>Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To establish the clinical FTE needs for providing urgent intravesical treatments</measure>
    <time_frame>baseline, through stufy completion, an average of one year</time_frame>
    <description>Nursing needs to provide intravesical treatments of acute Urinary Tract Infections (UTI) in women with chronic recurrent UTIs. Measured in amount of participants and FTE requirement for nursing staff.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Urinary Tract Infections</condition>
  <arm_group>
    <arm_group_label>Oral Nitrofurantoin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will randomized to oral nitrofurantoin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravesical Gentamicin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to intravesical gentamicin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrofurantoin</intervention_name>
    <description>Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days</description>
    <arm_group_label>Oral Nitrofurantoin</arm_group_label>
    <other_name>Macrobid, Furadantin, Macrodantin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gentamicin</intervention_name>
    <description>Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days</description>
    <arm_group_label>Intravesical Gentamicin</arm_group_label>
    <other_name>Gentak, Garamycin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand study procedures and to comply with them for the entire length&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who report that they are pregnant.&#xD;
&#xD;
          -  Patients with a positive urine pregnancy test&#xD;
&#xD;
          -  Patients with a history of renal transplantation.&#xD;
&#xD;
          -  Patients with bladder augmentation procedures using bowel.&#xD;
&#xD;
          -  Patients with poorly controlled Type II diabetes, Hgb A1C &gt;6.5%&#xD;
&#xD;
          -  Patients with spinal cord injury, ASIA Impairment Scale of C or higher.&#xD;
&#xD;
          -  Patients with pelvic surgery within 6 months.&#xD;
&#xD;
          -  Patients with urologic procedure within 6 months.&#xD;
&#xD;
          -  Patients with a history of reconstructive urologic surgery, such as reflux, congenital&#xD;
             abnormality.&#xD;
&#xD;
          -  Immunocompromised patients being treated for malignancy or a history of actively&#xD;
             treated malignancy within 5 years.&#xD;
&#xD;
          -  Patients with active systemic autoimmune disease.&#xD;
&#xD;
          -  Patients on systemic immunosuppression.&#xD;
&#xD;
          -  Use of antibiotic prophylaxis within 6 months&#xD;
&#xD;
          -  Use of antibiotics within 10 days of active infection&#xD;
&#xD;
          -  Allergy/sensitivity to gentamicin or nitrofurantoin.&#xD;
&#xD;
          -  Current drug or alcohol use or dependence that, in the opinion of the site&#xD;
             investigator, would interfere with adherence to study requirements.&#xD;
&#xD;
          -  Inability or unwillingness of individual to give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Premenopausal or perimenopausal healthy female patients with an active urinary tract infection and at least two symptomatic and culture-proven urinary tract infections within the past 12 months</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah Lightner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Audrey N Schuetz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Deborah J. Lightner</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>urinary tract</keyword>
  <keyword>infection</keyword>
  <keyword>recurrent</keyword>
  <keyword>women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gentamicins</mesh_term>
    <mesh_term>Nitrofurantoin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299387
org study id: 11-002887
nct id: NCT03299387
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Women have problems with oral antibiotics, including vagina and bowel infections. Also,
      bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement
      of antibiotic directly into the bladder does not cause these problems and are at doses that
      are may be able to stop bacteria from being resistant to antibiotics.
Each participant once enrolled returns with an active Urinary Tract Infection (UTI),
      confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent
      with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin
      treatment for 7 days, or intravesical gentamicin instillation once a day for three days.
      Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and
      with a repeated questionnaire for symptom relief.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in microbiologic effect of a chronic acute Urinary Tract Infection
time frame: baseline, 7-10 days
description: Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days
measure: Change in symptomatic relief of a chronic acute Urinary Tract Infection
time frame: baseline, 7-10 days
description: Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)
measure: To establish the clinical FTE needs for providing urgent intravesical treatments
time frame: baseline, through stufy completion, an average of one year
description: Nursing needs to provide intravesical treatments of acute Urinary Tract Infections (UTI) in women with chronic recurrent UTIs. Measured in amount of participants and FTE requirement for nursing staff.
arm group label: Oral Nitrofurantoin
arm group type: Active Comparator
description: Participants will randomized to oral nitrofurantoin
arm group label: Intravesical Gentamicin
arm group type: Active Comparator
description: Participants will be randomized to intravesical gentamicin
intervention type: Drug
intervention name: Nitrofurantoin
description: Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days
arm group label: Oral Nitrofurantoin
other name: Macrobid, Furadantin, Macrodantin
intervention type: Drug
intervention name: Gentamicin
description: Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days
arm group label: Intravesical Gentamicin
other name: Gentak, Garamycin
criteria: 
gender: Female
gender based: Yes
gender description: Premenopausal or perimenopausal healthy female patients with an active urinary tract infection and at least two symptomatic and culture-proven urinary tract infections within the past 12 months
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deborah Lightner, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Audrey N Schuetz, MD
role: Principal Investigator
affiliation: Mayo Clinic
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Deborah J. Lightner
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Gentamicins
mesh term: Nitrofurantoin
sharing ipd: No