Trials / Withdrawn
WithdrawnNCT03299387
INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI
INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nitrofurantoin | Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days |
| DRUG | Gentamicin | Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days |
Timeline
- Start date
- 2017-06-28
- Primary completion
- 2018-07-05
- Completion
- 2018-07-05
- First posted
- 2017-10-03
- Last updated
- 2019-06-06
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03299387. Inclusion in this directory is not an endorsement.