Efficacy and safety of oral fosfomycin trometamol for the treatment of lower urinary tract infections caused by multi drug resistant bacteria：an open-label, uncontrolled, multicenter study / 中华泌尿外科杂志

ABSTRACT

Objective To assess the efficacy and safety of oral fosfomycin trometamal in patients with lower urinary tract infections ( UTIs) caused by multi drug resistant ( MDR) bacteria in the clinical setting in China.Methods Multicenter study was conducted from January 2011 to December 2011 in 12 hospitals in China.Three hundred and fifty-six patients with non-fever lower UTls were treated by fosfomycin trometamal 3 g once daily.Three hundred and fifty cases with complete data were further evaluated .One hundred and twenty ( 34.3%) were male and 230 ( 65.7%) were female.The average age was ( 49.9 ± 16.6) years.Depending of the results of urine culture at the first visit ,142 patients with E.coli, Klebsiella pneumonia, proteus, Staphylococcus aureus, Staphylococcus epidermidis and entercocous were analyzed.The susceptibility of MDR bacteria to fosfomycin trometamol were calculated . The clinical efficacy , bacteriological efficacy of fosfomycin trometamol to these patients was evaluated .Results For the gram-negative bacteria detected by culture , among the E.coli, Klebsiella pneumonia and proteus, 50%(52/104) were Extended-Spectrum β-lactamases producing organisms . For the gram-positive bacteria ( n =38 ) detected by culture, methicillin-resistant staphylococcus accounts for 55%(11/20) of all the Staphylococcus and the other gram-positive bacteria were Enterococcus ( n=18 ) .Higher susceptibility rates to fosfomycin trometamol were observed among MDR bacteria (85.7%) and the clinical effective rate and bacteriological effective rate of fosfomycin trometamol were 96.4%( 53/55 ) and 87.5%( 42/48 ) , respectively .The incidence of drug-related adverse events (AEs) was 5.6%(20/356).The most common AE was diarrhea. No drug-related serious adverse events were found .Conclusions The distributions of uropathogens in China are complicated. The detection rate of MDR uropathogens is high . The dosing regimen of fosfomycin trometamal 3 g once daily is effective and tolerable for the patients with lower UTIs caused by MDR bacteria . It may represent good options for the empiric therapy for the patients with lower UTIs .