Potentiated Aminoglycosides in Postoperative Urinary Tract Infection Prophylaxis
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
Urinary tract hardware such as pig-tail catheters are are frequently used for management of
urolithiasis or other obstructive pathologies. They are readily colonized by urogenital flora
leading to asymptomatic bacteriuria. While asymptomatic bacteriuria is not per se a problem
for patients, it may lead to severe infections in the context of hardware manipulation
leading to mucosal damage (e.g. catheter exchanges or stone extraction). Such interventions
therefore warrant an antibiotic prophylaxis. However, bacteria rapidly form biofilms on
hardware; aside of fluoroquinolones, antibiotics have limited anti-biofilm activity.
Furthermore, the widespread use of antibiotics has lead to resistant strains. Hence, novel
antimicrobial strategies are needed. Recently, metabolism-based potentiation of
aminoglycoside has shown high antimicrobial activity against persistent forms of bacteria
such as biofilms in the context of murine catheter-associated urinary tract infections.
Because of the highly favorable pharmacodynamic profile of aminoglycoside in the urinary
tract and the metabolic potentiation, aminoglycosides can be reduced to levels with minimal
toxicity.
UROPOT aims to compare the efficacy of potentiated aminoglycoside to standard of care for (i)
prophylaxis of asymptomatic bacteriuria during urinary hardware manipulations with mucosal
trauma (Pig-tail catheter exchange, stone surgery with prior in-dwelling catheter, etc.) and
(ii) sustained microbiological eradication through antibiofilm activity. UROPOT will compare
the rate of post-interventional urinary tract infections (primary outcome). It will also
assess safety and eradication potency (microbiological outcome).
Phase:
Early Phase 1
Details
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborators:
Ecole Polytechnique Fédérale de Lausanne University Hospital Inselspital, Berne