Perioperative fosfomycin disodium prophylaxis against urinary tract infection in renal transplant recipients: A randomized clinical trial

Abstract

ackground. Symptomatic urinary tract infection (UTI) is the most common infectious complication in renal transplant ecipients (RTRs). Fosfomycin (FOS) is an attractive alternative or prophylaxis because it does not interact with immunosupressants; although 90% is excreted unchanged in the urine, it oes not require adjustment for renal function for single dose rophylaxis. Methods. RTRs were recruited into this randomized, doublelind, placebo-controlled trial. Participants were randomized 1:1) to receive one 4 g dose of FOS disodium intravenously 3 h FOS group) or placebo (placebo group) before placement and emoval of a urinary catheter and before removal of a double-J reteral stent. All participants received prophylaxis with rimethoprim/sulfamethoxazole. The main outcome was a com-arison of the mean number of symptomatic UTI and asympomatic bacteriuria (AB) episodes per patient during a 7-week ollow-up period. The study was registered at ClinicalTrials.gov, NTC03235947. Results. Eighty-two participants were included (41 in the FOS roup and 41 in placebo group). The mean number of AB or ymptomatic UTI episodes per patient was lower in the FOS roup [intention-to-treat (ITT) 0.29 versus 0.60, P ¼ 0.04]. The ncidence of symptomatic UTI was lower in the FOS group ITT, 7.3% versus 36.6%, P ¼ 0.001), and there was no differnce in the incidence of AB between both groups. The incidence f adverse events was similar in both groups. Conclusions. FOS addition is an effective and safe strategy to reduce the number of symptomatic UTIs during the first 7 weeks after renal transplant.