Session: MP34: Infections/Inflammation/Cystic Disease of the Genitourinary Tract: Kidney & Bladder I
MP34-16: Randomized Phase II Study of Antibiotic Prophylaxis With Oral 3 gr Fosfomycin Tromethamine vs preoperative Amikacin 1 gr I.V. in patients undergoing Transurethral Resection of the Bladder
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Introduction: Urinary tract infections are one of the most common complications following transurethral resection of the bladder (TURBT). Antibiotic prophylaxis is indicated in every patient, however recommendations are essentially empiric and based on older studies. An adequate prophylaxis should be tailored on local microbiological data to minimize postoperative infectious complications. The aim of this study was to compare preoperative oral 3 gr Fosfomycin tromethamine vs intravenous 1 gr amikacin administration in patients undergoing TURBT. Methods: Between January 2020 and November 2022, a double blind, phase II randomized clinical trial was conducted in a tertiary center in Mexico City. Patients undergoing TURBT were randomly assigned to two groups; oral Fosfomycin Tromethamine 3 gr (one day before) vs. preoperative amikacin 1 gr I.V. (control group). The primary endpoints were the development of urinary tract infection (UTI), asymptomatic bacteriuria (AB) and sepsis 30 days after surgical resection. Every patient had a negative preoperative urine culture, absence of urinary symptoms, no use of antibiotics 15 days prior to surgery and no indwelling catheters. Baseline and perioperative characteristics were compared between study groups. Relative risk and independent risk factors for the development of UTI and/or AB were calculated. Every patient had a postoperative midstream urine culture 1 month after surgical resection. This study was IRB approved and was registered in clinicaltrials.gov, NCT 04209192. Results: Seventy five patients were included in the study and 71 completed follow up (control group n=37) and were further analyzed. There were no significant differences in baseline characteristics between study groups (age, sex, comorbidities, smoking status, ECOG score, ASA score) and no differences in perioperative characteristics (surgical time, number of tumors, tumor size, bleeding, and postoperative catheter duration). There were no differences in postoperative UTI (11.8% vs 5.4% in control group, p= 0.42) and AB (2.9% vs. 8.1% in control group, p = 0.62) between study groups. No patient developed postoperative sepsis. No adverse effects related to antibiotic use were reported in this study. Conclusions: There were no significant differences in the development of infectious complications following TURBT between study groups. Oral 3 gr Fosfomycin tromethamine may be a reasonable alternative for prophylaxis in these patients. SOURCE OF Funding: none
