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Trial record 8 of 1848 for:    "Mayo Clinic" [Exact]

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

This study is currently recruiting participants.
Verified September 2017 by Deborah J. Lightner, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT03299387
First Posted: October 3, 2017
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Deborah J. Lightner, Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Urinary Tract Infections Drug: Nitrofurantoin Drug: Gentamicin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Deborah J. Lightner, Mayo Clinic:

Primary Outcome Measures:
  • Change in microbiologic effect of a chronic acute Urinary Tract Infection [ Time Frame: baseline, 7-10 days ]
    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 [ Time Frame: baseline, 7-10 days ]
    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 [ Time Frame: baseline, through stufy completion, an average of one year ]
    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.


Estimated Enrollment: 40
Actual Study Start Date: June 28, 2017
Estimated Study Completion Date: July 14, 2019
Estimated Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Nitrofurantoin
Participants will randomized to oral nitrofurantoin
Drug: Nitrofurantoin
Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days
Other Name: Macrobid, Furadantin, Macrodantin
Active Comparator: Intravesical Gentamicin
Participants will be randomized to intravesical gentamicin
Drug: Gentamicin
Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days
Other Name: Gentak, Garamycin

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299387


Contacts
Contact: Deborah J Lightner, MD 507-284-6784 lightner.deborah@mayo.edu
Contact: Abinash Virk, MD 507-284-6788 virka@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Deborah Lightner, MD    507-284-6784    lightner.deborah@mayo.edu   
Principal Investigator: Deborah Lightner, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Deborah Lightner, MD Mayo Clinic
Principal Investigator: Audrey N Schuetz, MD Mayo Clinic
  More Information

Responsible Party: Deborah J. Lightner, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03299387     History of Changes
Other Study ID Numbers: 11-002887
First Submitted: September 20, 2017
First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Deborah J. Lightner, Mayo Clinic:
urinary tract
infection
recurrent
women

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Gentamicins
Anti-Infective Agents
Nitrofurantoin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents