Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial.
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Lafaurie Matthieu, Chevret Sylvie, Fontaine Jean-Paul, Mongiat-Artus Pierre, de Lastours Victoire, Escaut Lélia, Jaureguiberry Stéphane, Bernard Louis, Bruyere Franck, Gatey Caroline, Abgrall Sophie, Ferreyra Milagros, Aumaitre Hugues, Aparicio Caroline, Garrait Valérie, Meyssonnier Vanina, Bourgarit-Durand Anne, Chabrol Amélie, Piet Emilie, Talarmin Jean-Philippe, Morrier Marine, Canoui Etienne, Charlier Caroline, Etienne Manuel, Pacanowski Jerome, Grall Nathalie, Desseaux Kristell, Empana-Barat Florence, Madeleine Isabelle, Bercot Béatrice, Molina Jean-Michel, Lefort Agnès, PROSTASHORT Study Group
Аннотация
METHODS: To compare 7 days to 14 days of total antibiotic treatment for febrile UTIs in men, this multicenter randomized, double-blind. placebo-controlled noninferiority trial enrolled 282 men from 27 centers in France. Men were eligible if they had a febrile UTI and urine culture showing a single uropathogen. Participants were treated with ofloxacin or a 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 and the absence of fever and of subsequent antibiotic treatment between the end of treatment and 6 weeks after day 1. Secondary endpoints included recurrent UTI within weeks 6 and 12 after day 1, rectal carriage of antimicrobial-resistant Enterobacterales, and drug-related events.
RESULTS: Two hundred forty participants were randomly assigned to receive antibiotic therapy for 7 days (115 participants) or 14 days (125 participants). In the intention-to-treat 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 [95% confidence interval, -33.3 to -10.1]), demonstrating inferiority. Adverse events during antibiotic therapy were reported in 4 participants in the 7-day arm and 7 in the 14-day arm. Rectal carriage of resistant Enterobacterales did not differ between both groups.
CONCLUSIONS: A treatment with ofloxacin for 7 days was inferior to 14 days for febrile UTI in men and should therefore not be recommended.
CLINICAL TRIALS REGISTRATION: NCT02424461; Eudra-CT: 2013-001647-32.