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

NCT ID: NCT03299387

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2018-07-05

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Nitrofurantoin

Participants will randomized to oral nitrofurantoin

Group Type: ACTIVE_COMPARATOR

Nitrofurantoin

Intervention Type: DRUG

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

Intravesical Gentamicin

Participants will be randomized to intravesical gentamicin

Group Type: ACTIVE_COMPARATOR

Gentamicin

Intervention Type: DRUG

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

Interventions

Nitrofurantoin

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

Intervention Type: DRUG

Gentamicin

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

Intervention Type: DRUG

Other Intervention Names

Macrobid, Furadantin, Macrodantin; Gentak, Garamycin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Deborah J. Lightner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Lightner, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Audrey N Schuetz, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

11-002887

Identifier Type: -

Identifier Source: org_study_id