NL-OMON38402
Completed
Not Applicable
Prevention of recurrent urinary tract infections by multi-drug resistant bacteria, by intravesical administration of gentamicin. - SPRING
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrent urinary tract infection
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 170
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Competent patient aged 18 or above.
- •2\. A history of recurrent cystitis, defined as:
- •a. females: at least 2 episodes of UTI in the last 6 months or 3 in the last 12 months
- •b. males: at least 2 episodes of UTI in the last 12 months (including recurrent cystitis likely due to chronic bacterial prostatitis).
- •3\. At least one episode of these infections is documented by urine culture with the isolation of \*10^3 CFU/mL of an identified MDR pathogen. Multidrug resistance is defined as acquired non\-susceptibility to at least one agent in three or more antimicrobial classes.
- •4\. All other episodes at least by one urinary symptom\* and positive urinary nitrate test or leukocyturia (as depicted by positive leukocyte esterase test or microscopy).
- •5\. No clinical symptoms of UTI at enrolment.
Exclusion Criteria
- •1\. Urinary culture in prior 6 months tested positive for high\-level gentamicin resistant enterobacteriaceae or enterococci (MIC \>128 mg/L).
- •2\. Abnormalities of the upper urinary tract, including presence of urinary stones.
- •3\. Patients with a permanent urinary catheter.
- •4\. Complete urinary incontinence.
- •5\. Patients with stage 5 chronic kidney disease (GFR \<15 ml/min).
- •6\. Patients with known hypersensitivity to gentamicin.
- •7\. Pregnancy or lactation.
- •8\. Inability to provide informed consent.
Outcomes
Primary Outcomes
Not specified
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