Fosfomycin trometamol in the prophylaxis of post‐kidney transplant urinary tract infection: A controlled, randomized clinical trial. Issue 5 (10th September 2018)

• Record Type: Journal Article
• Authors: Arreola‐Guerra, José M.; Rosado‐Canto, Rodrigo; Alberú, Josefina; Maravilla, Ernesto; Torres‐González, Pedro; Criollo, Elia; Pérez, Maria; Mancilla, Eduardo; Arvizu, Mauricio; Morales‐Buenrostro, Luis Eduardo; Vilatobá‐Chapa, Mario; Sifuentes‐Osornio, José
• Is Part Of: Transplant infectious disease. Volume 20:Issue 5(2018)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2018-09-10
• Subjects: asymptomatic bacteriuria -- fosfomycin -- prophylaxis -- trimethoprim/sulfamethoxazole -- urinary tract infection; Transplantation of organs, tissues, etc -- Complications -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 617.01
• DOI: 10.1111/tid.12980
• Languages: English
• ISSNs: 1398-2273

Abstract

Abstract: Background: The aim of this controlled clinical trial was to evaluate the efficacy and safety of fosfomycin trometamol (FOS) in urinary tract infection (UTI) prophylaxis during the first 6 months after renal transplant (RT). Methods: The intervention group received 3 g of FOS PO every 10 days and trimethoprim‐sulfamethoxazole (TMP‐SMX, 160/800 mg) three times per week (Group 1), whereas the control group received TMP‐SMX (160/800 mg) daily (Group 2). The outcomes were the time until the first UTI (symptomatic infection or asymptomatic bacteriuria (>10 5 CFU/mL)) and the incidence of UTI during the first 6 months post RT. Intermediate analysis was conducted after one‐half of the estimated sample size of patients was enrolled. Results: The recruitment of patients was stopped after the intermediate analysis due showed no emerging trends or reasonable chance of demonstrating benefit. Sixty‐seven patients were included (32 in Group 1 and 35 in Group 2). The UTI incidence (40.6% vs 42.8%, P = 0.85) and time until the first episode were similar between the groups (log rank, P = 0.862). UTI due to Klebsiella spp . was observed in both groups at equal rates (25% vs 20%, P = 0.62), episodes due to Escherichia coli were less frequent in Group 1 (12.5% vs 34.2%, P = 0.04), and Enterococcus faecalis infection only occurred in Group 2 (n = 4). Resistance to FOS was observed for Klebsiella spp .; in contrast, E. coli and E. faecalis were susceptible. Conclusions: The addition of FOS to TMP‐SMX was not beneficial for the prevention of UTI after RT in our setting. (ClinicalTrials.gov, NCT01820897).