Status:
WITHDRAWN
INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI
Lead Sponsor:
Mayo Clinic
Conditions:
Urinary Tract Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 dire...
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-febri...
Eligibility Criteria
Inclusion
- Ability to understand study procedures and to comply with them for the entire length of the study.
Exclusion
- 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.
Key Trial Info
Start Date :
June 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03299387
Start Date
June 28 2017
End Date
July 5 2018
Last Update
June 6 2019
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