Abstract
Background
The optimal duration of antimicrobial therapy for urinary tract infections in men remains controversial.
Methods
To compare 7 days to 14 days total antibiotic treatment for febrile urinary tract infections in men, this multicenter randomized, double-blind placebo-controlled non-inferiority trial enrolled 282 men from 27 centers in France. Men were eligible if they had a febrile urinary tract infection and urine culture showing a single uropathogen.Participants were treated with ofloxacin or third generation cephalosporin at day 1, then randomized at day 3-4 to either continue ofloxacin for 14 days total treatment, or for 7 days followed by placebo until day 14.The primary endpoint was treatment success, defined as a negative urine culture, the absence of fever and of subsequent antibiotic treatment between the end of treatment and 6 weeks after day 1. Secondary endpoints included recurrent urinary tract infection within weeks 6 and 12 after day 1, rectal carriage of antimicrobial-resistant
Enterobacterales and drug-related events.
Results
Two hundred and forty participants were randomly assigned to receive antibiotic therapy for 7 (115 participants) or 14 days (125 participants). In the ITT analysis, treatment success occurred in 64 participants (55.7%) in the 7-day group and in 97 participants (77.6%) in the 14-day group (risk difference-21.9 (-33.3 to -10.1)), demonstrating inferiority. Adverse events during antibiotic therapy were reported in four participants in the 7-day arm and seven in the 14-day arm. Rectal carriage of resistant
Enterobacterales did not differ between both groups.
Conclusion
A treatment with ofloxacin for 7 days was inferior to 14 days for febrile UTI in men and should therefore not be recommended.
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