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

NCT03299387 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 11-002887
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infections

Keywords

urinary tract; infection; recurrent; women

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  baseline, through stufy completion, an average of one year

Study Arms (2)

Oral Nitrofurantoin

ACTIVE COMPARATOR

Participants will randomized to oral nitrofurantoin

Drug: Nitrofurantoin

Intravesical Gentamicin

ACTIVE COMPARATOR

Participants will be randomized to intravesical gentamicin

Drug: Gentamicin

Interventions

Nitrofurantoin DRUG

Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days

Also known as: Macrobid, Furadantin, Macrodantin

Oral Nitrofurantoin

Gentamicin DRUG

Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days

Also known as: Gentak, Garamycin

Intravesical Gentamicin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Urinary Tract Infections; Infections; Recurrence

Interventions

Nitrofurantoin; Gentamicins

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Deborah Lightner, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Audrey N Schuetz, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 3, 2017
• Study Start: June 28, 2017
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share