search
Back to results

INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI (INSTANT)

Primary Purpose

Urinary Tract Infections

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nitrofurantoin
Gentamicin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring urinary tract, infection, recurrent, women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

  • Patients who report that they are pregnant.
  • Patients with a positive urine pregnancy test
  • Patients with a history of renal transplantation.
  • Patients with bladder augmentation procedures using bowel.
  • Patients with poorly controlled Type II diabetes, Hgb A1C >6.5%
  • Patients with spinal cord injury, ASIA Impairment Scale of C or higher.
  • Patients with pelvic surgery within 6 months.
  • Patients with urologic procedure within 6 months.
  • Patients with a history of reconstructive urologic surgery, such as reflux, congenital abnormality.
  • Immunocompromised patients being treated for malignancy or a history of actively treated malignancy within 5 years.
  • Patients with active systemic autoimmune disease.
  • Patients on systemic immunosuppression.
  • Use of antibiotic prophylaxis within 6 months
  • Use of antibiotics within 10 days of active infection
  • Allergy/sensitivity to gentamicin or nitrofurantoin.
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual to give written informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Oral Nitrofurantoin

    Intravesical Gentamicin

    Arm Description

    Participants will randomized to oral nitrofurantoin

    Participants will be randomized to intravesical gentamicin

    Outcomes

    Primary Outcome Measures

    Change in microbiologic effect of a chronic acute Urinary Tract Infection
    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
    Change in symptomatic relief of a chronic acute Urinary Tract Infection
    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)

    Secondary Outcome Measures

    To establish the clinical FTE needs for providing urgent intravesical treatments
    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.

    Full Information

    First Posted
    September 20, 2017
    Last Updated
    June 4, 2019
    Sponsor
    Mayo Clinic
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03299387
    Brief Title
    INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI
    Acronym
    INSTANT
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never recruited
    Study Start Date
    June 28, 2017 (Actual)
    Primary Completion Date
    July 5, 2018 (Actual)
    Study Completion Date
    July 5, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infections
    Keywords
    urinary tract, infection, recurrent, women

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral Nitrofurantoin
    Arm Type
    Active Comparator
    Arm Description
    Participants will randomized to oral nitrofurantoin
    Arm Title
    Intravesical Gentamicin
    Arm Type
    Active Comparator
    Arm Description
    Participants will be randomized to intravesical gentamicin
    Intervention Type
    Drug
    Intervention Name(s)
    Nitrofurantoin
    Other Intervention Name(s)
    Macrobid, Furadantin, Macrodantin
    Intervention Description
    Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Gentamicin
    Other Intervention Name(s)
    Gentak, Garamycin
    Intervention Description
    Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days
    Primary Outcome Measure Information:
    Title
    Change in microbiologic effect of a chronic acute Urinary Tract Infection
    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
    Time Frame
    baseline, 7-10 days
    Title
    Change in symptomatic relief of a chronic acute Urinary Tract Infection
    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)
    Time Frame
    baseline, 7-10 days
    Secondary Outcome Measure Information:
    Title
    To establish the clinical FTE needs for providing urgent intravesical treatments
    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.
    Time Frame
    baseline, through stufy completion, an average of one year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility 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 & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to understand study procedures and to comply with them for the entire length of the study. Exclusion Criteria: Patients who report that they are pregnant. Patients with a positive urine pregnancy test Patients with a history of renal transplantation. Patients with bladder augmentation procedures using bowel. Patients with poorly controlled Type II diabetes, Hgb A1C >6.5% Patients with spinal cord injury, ASIA Impairment Scale of C or higher. Patients with pelvic surgery within 6 months. Patients with urologic procedure within 6 months. Patients with a history of reconstructive urologic surgery, such as reflux, congenital abnormality. Immunocompromised patients being treated for malignancy or a history of actively treated malignancy within 5 years. Patients with active systemic autoimmune disease. Patients on systemic immunosuppression. Use of antibiotic prophylaxis within 6 months Use of antibiotics within 10 days of active infection Allergy/sensitivity to gentamicin or nitrofurantoin. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Inability or unwillingness of individual to give written informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deborah Lightner, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Audrey N Schuetz, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI

    We'll reach out to this number within 24 hrs