Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Matthieu Lafaurie, Sylvie Chevret, Jean-Paul Fontaine, Pierre Mongiat-Artus, Victoire de Lastours, L. Escaut, Stéphane Jauréguiberry, Louis Bernard, Franck Bruyere, Caroline Gatey, Sophie Abgrall, Milagros Ferreyra, Hugues Aumaître, C. Aparicio, Valérie Garrait, Vanina Meyssonnier, A. Bourgarit-Durand, Amélie Chabrol, Emilie Piet, Jean‐Philippe Talarmin, Marine Morrier, Étienne Canouï, Caroline Charlier, Manuel Etienne, Jérôme Pacanowski, Nathalie Grall, Kristell Desseaux, Florence Empana-Barat, Isabelle Madeleine, Béatrice Berçot, Jean‐Michel Molina, Agnès Lefort, for the PROSTASHORT Study Group, Matthieu Lafaurie, Sylvie Chevret, Jean-Paul Fontaine, Pierre Mongiat-Artus, Victoire de Lastours, L. Escaut, Stéphane Jauréguiberry, Louis Bernard, Franck Bruyere, Caroline Gatey, Sophie Abgrall, Milagros Ferreyra, Hugues Aumaître, C. Aparicio, Valérie Garrait, Vanina Meyssonnier, A. Bourgarit-Durand, Amélie Chabrol, Emilie Piet, Jean‐Philippe Talarmin, Marine Morrier, Étienne Canouï, Caroline Charlier, Manuel Etienne, Jérôme Pacanowski, Nathalie Grall, Kristell Desseaux, Florence Empana-Barat, Isabelle Madelaine, Béatrice Berçot, Jean‐Michel Molina, Agnès Lefort, Sylvia Olive, Albert Sotto, Pierre Tattevin, Esther Simon-Libchaber, Giovanna Melica, R. Lepeule, Sophie Alviset, Nicolas Fortineau, Antoine Froissart, V. Delcey, Romain Dufau, Xavier Lescure, Martin Martinot, G. Gavazzi, Marie‐Charlotte Chopin, Arthur Lehel, Nabil Raked, Cécile Kedzia, Stéphane Lo, Romain Bricca, Gilles Dumondin, X. Lemaire, Aurélien Dinh
Abstract
BACKGROUND: The optimal duration of antimicrobial therapy for urinary tract infections (UTIs) in men remains controversial. 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.