Randomized Phase II Study of Antibiotic Prophylaxis With Fosfomycin vs Amikacin in Transurethral Resection of Bladder

URO-2995-19-20-1

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.

2020-01-01

2023-04-01

2023-04-01

Completed

Early phase I

75

Inclusion Criteria: * Patients 18 years old of age * Patients with a programmed TURB * Absence of urinary tract infection (negative urine culture and no clinical manifestations for urinary tract infection) Exclusion Criteria: * Patients with asymptomatic bacteriuria * Patients with positive urine culture before procedure * Patients with urinary catheterization

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2023-04-04