FOSFORMEN : Randomized, multicenter, non-inferiority trial comparing the efficacy of fosfomycin versus fluoroquinolones or cotrimoxazole as oral follow-up treatment in febrile urinary tract infections in men caused by susceptible enterobacteria

Febrile male urinary tract infections caused by Escherichia coli

The primary endpoint will be a binary outcome, defined as clinical cure (body temperature < 38°C and absence of urinary tract infection symptoms), without the need for additional antibiotic therapy up to the primary evaluation on Day 26, which corresponds to 14 days after completion of a 12-day antibiotic treatment assigned by randomization.

To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) the cumulative incidence of infectious and urological complications, To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) adherence to treatment, occurrence, nature, and severity of adverse events related to antibiotics, To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) rectal carriage of phenotypically antibiotic-resistant Enterobacterales (resistant to FQ, TMP-SMX, fosfomycin, and thired-generation cephalosporins) on Day 26, i.e., 14 days after completion of the randomized antibiotic treatment, To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) rates of recurrence of febrile or non-febrile UTIs (relapse or reinfection), assessed on Day40, i.e., 28 days after completion of the randomized antibiotic treatment, To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) analysis of clinical and biological characteristics of patients who experienced treatment failure compared to those who were cured during the initial episode.

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