Potentiated Aminoglycosides in Postoperative Urinary Tract Infection Prophylaxis

Launched by CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial, called UROPOT, is studying a new approach to prevent urinary tract infections (UTIs) in patients who have special tubes, called ureteral stents, placed in their urinary system. These stents are often used during surgeries to treat kidney stones or other blockages. While some bacteria can live harmlessly in the urinary tract, they can cause serious infections when medical devices are manipulated. The trial is comparing a newly developed antibiotic treatment, which is based on aminoglycosides, to standard antibiotic care. The goal is to see if the new treatment is more effective at preventing UTIs and eliminating harmful bacteria.

To be eligible for this trial, participants must be adults aged 18 or older, have a ureteral stent in place, and have certain types of bacteria in their urine that are sensitive to the study drugs. They should not have certain health conditions, such as severe kidney issues or allergies to the study medications. If someone joins the study, they can expect to receive treatment and regular monitoring to ensure their safety and track how well the treatment works. This trial is currently recruiting participants, and it aims to find a safer and more effective way to prevent infections in patients undergoing procedures involving urinary hardware.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent
• • Adults (≥18 years)
• • Ureteral stent in situ
• • Patients scheduled for endourological ureteral manipulations (e.g. endourological stone surgery, ureteral stent exchange)
• • Asymptomatic bacteriuria with strains of E. coli and/or K. pneumoniae sensitive to Ceftriaxone and Amikacin/Aminoglycosides.
• Exclusion Criteria:
• • Allergy to one of the study drugs Beta-lactams, aminoglycosides or mannitol
• • Pregnant and lactating women
• • Glomerular filtration rate (CKD-EPI eGFR) \< 50ml/min / 1,73m2
• • Hearing impairment
• • Myasthenia gravis or other forms of myoneural disorders
• • Congestive heart failure, Pulmonary edema
• • Intracranial hemorrhage, blood-brain barrier compromise
• • Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial
• • Antibiotic treatment within 14 days prior to randomization
• • Mixed cultures of E. coli and/or K. pneumonia with other bacteria
• • Inability to understand and follow the protocol
• • Inability to give informed consent
• • BMI\<20 or \>30