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Fosfomycin trometamol in the prophylaxis of post‐kidney transplant urinary tract infection: A controlled, randomized clinical trial
Author(s) -
ArreolaGuerra José M.,
RosadoCanto Rodrigo,
Alberú Josefina,
Maravilla Ernesto,
TorresGonzález Pedro,
Criollo Elia,
Pérez Maria,
Mancilla Eduardo,
Arvizu Mauricio,
MoralesBuenrostro Luis Eduardo,
VilatobáChapa Mario,
SifuentesOsornio José
Publication year - 2018
Publication title -
transplant infectious disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.69
H-Index - 67
eISSN - 1399-3062
pISSN - 1398-2273
DOI - 10.1111/tid.12980
Subject(s) - medicine , fosfomycin , urinary system , bacteriuria , gastroenterology , trimethoprim , incidence (geometry) , enterococcus faecalis , urine , sulfamethoxazole , antibiotics , microbiology and biotechnology , escherichia coli , biochemistry , chemistry , physics , optics , gene , biology
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, NCT 01820897).