Prevention of recurrent urinary tract infections by multi-drug resistant bacteria, by intravesical administration of gentamicin. - SPRING

eids Universitair Medisch Centrum0 个研究点目标入组 170 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•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.

•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.

发起方