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

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03299387

Collaborator

(none)

Enrollment

Arms

12.2

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Drug: Nitrofurantoin Drug: Gentamicin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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)

Actual Study Start Date :

Jun 28, 2017

Actual Primary Completion Date :

Jul 5, 2018

Actual Study Completion Date :

Jul 5, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in microbiologic effect of a chronic acute Urinary Tract Infection [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.