Abstract
PurposeTo compare efficacy, safety, and cost-effectiveness of fosfomycin tromethamine with other standard-of-care antibiotics in patients undergoing ureteroscopic lithotripsy.MethodsThis study was a prospective, multicenter, randomized, controlled trial. Eligible patients scheduled for ureteroscopic lithotripsy were randomly assigned to receive either fosfomycin (fosfomycin group, N = 101 patients) or standard-of-care antibiotic therapy as prophylaxis (control group, N = 115 patients). The incidence of infectious complications and adverse events was analyzed between the two groups, as well as the cost–benefit analysis.ResultsThe incidence of infections following lithotripsy was 3.0% in the fosfomycin group and 6.1% in the control group (p > 0.05). Only asymptomatic bacteriuria was reported in fosfomycin group. In the control group was reported asymptomatic bacteriuria (3.5%), fever (0.9%), bacteremia (0.9%), and genitourinary infection (0.9%). The rate of adverse events was very low, with no adverse event reported in the fosfomycin group and only one in the control group (forearm phlebitis). The average cost per patient of antibiotic therapy with fosfomycin was 151.45 ± 8.62 yuan (22.7 ± 1.3 USD), significantly lower compared to the average cost per patient of antibiotics used in the control group 305.10 ± 245.95 yuan (45.7 ± 36.9 USD; p < 0.001).ConclusionsTwo oral doses of 3 g fosfomycin tromethamine showed good efficacy and safety and low cost in perioperative prophylaxis of infections following ureteroscopic stone removal.
Highlights
Due to crossover of antireflux barrier of the ureter, ureteroscopic procedures, including ureteroscopic stone removal, are associated with an increased risk of dissemination of pathogens from lower urinary tract to the upper tract and with an increased risk of post-procedure infections [1, 2]
While consensus exists on the need for antibiotic prophylaxis, guidelines on periprocedural prophylaxis in urological interventions recommend either fluoroquinolones or trimethoprim–sulfamethoxazole as first-line therapy [3] or to choose antibiotic regimen based on local epidemiology of drug resistance of potential pathogens [4] or based on the presence of other risk factors for infection and stone localization [6]
The emergence of resistant strains, including strains producing extended-spectrum β-lactamase (ESBL), and safety issues related to fluoroquinolones has increased the interest in finding other antibiotics that can be used in urinary tract infections (UTIs) prophylaxis and therapy [3, 8]
Summary
Due to crossover of antireflux barrier of the ureter, ureteroscopic procedures, including ureteroscopic stone removal, are associated with an increased risk of dissemination of pathogens from lower urinary tract to the upper tract and with an increased risk of post-procedure infections [1, 2]. In China, the most frequently used antibiotics for the treatment of urinary tract infections (UTIs) and their prophylaxis post-endourologic procedures have been cephalosporins and fluoroquinolones [7]. The experience with fosfomycin for treatment of UTIs is growing in China, no data are yet available on its use for prophylaxis of infections post-ureteroscopic stone removal. In this context, we aimed to assess the efficacy and safety of fosfomycin tromethamine in the prophylaxis of infectious complications post semi-rigid ureteroscopic lithotripsy
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