Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
Antimicrobial prophylaxis in urological procedures is aimed to reduce the risk of local and
systemic postoperative infections such as urinary tract infection or surgical site infection.
It should be recommended only when the potential benefit exceeds the anticipated risks and
costs. However, a wide variation in the use of periprocedural prophylactic antibiotics has
been demonstrated, which frequently is incurred as an inappropriate selection of
antimicrobials, inadequate schedule of administration or excessive duration of prophylaxis.
The increase in multidrug resistance of antibiotics in recent decades has been associated
with its misuse, resulting in an increased rate of morbidity and mortality, prolonged
hospital stays and increased care costs. Specifically, resistance to fluoroquinolones has
increased its prevalence, a group of antibiotics widely used in urology. Therefore, local
resistance patterns should be considered before following recommendations, especially in
populations with poor control of antimicrobial use.
Transurethral resection of bladder (TURB) has become a frequent surgical procedure, as it is
the main diagnostic and therapeutic tool for bladder cancer, representing the ninth most
common malignancy in the world. However, no recent randomized clinical trial has investigated
antimicrobial prophylaxis for TURB. It is well known that an expected complication of TURB is
urinary tract infection (UTI), which is the most common healthcare related infection
worldwide.
Under this premise, a randomized clinical trial is proposed to analyze the current panorama
of UTI as a transcendent postoperative complication of TURB, under the context of the new
emerging resistance parameters. The use of fosfomycin trometamol is proposed as a good
potential option for urological procedures due to its high activity against
multidrug-resistant gram-negative bacteria and its favorable pharmacokinetic parameters that
guarantees wide tissue penetration and a high urinary concentration, in a single dose, the
which will be compared with the control group with traditional prophylaxis (amikacin). The
relative risk of UTI will be estimated, as well as the attributable risk of the main risk
factors associated with this infection, allowing a better characterization of this population
for adequate decision making regarding this clinical challenge.
Phase:
Phase 2
Details
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran