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

INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)

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.

Study Overview

• Status: Withdrawn
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Nitrofurantoin; Drug: Gentamicin

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Gentak, Garamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, 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)	baseline, 7-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, through stufy completion, an average of one year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Deborah Lightner, MD, Mayo Clinic; Principal Investigator: Audrey N Schuetz, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): July 5, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: infection; women; recurrent; urinary tract
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Gentamicins; Nitrofurantoin
• Other Study ID Numbers: 11-002887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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