Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Authors: 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 ,   for the PROSTASHORT Study Group, 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 , Pharm.D Florence Empana-Barat , Pharm.D Isabelle Madelaine , Bercot Béatrice , Molina Jean-Michel , Lefort Agnès , Olive Sylvia , Sotto Albert , Tattevin Pierre , Simon-Libchaber Esther , Melica Giovanna , Lepeule Raphael , Alviset Sophie , Fortineau Nicolas , Froissart Antoine , Delcey Véronique , Dufau Romain , Lescure Xavier , Martinot Martin , Gavazzi Gaëtan , Chopin Marie-Charlotte , Lehel Arthur , Raked Nabil , Kedzia Cécile , Lo Stéphane , Bricca Romain , Dumondin Gilles , Lemaire Xavier , Dinh Aurélien 
Published: February 2023

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.