Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Resource type
Journal Article
Title
Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Abstract
The optimal duration of antimicrobial therapy for urinary tract infections (UTIs) in men remains controversial.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.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.A treatment with ofloxacin for 7 days was inferior to 14 days for febrile UTI in men and should therefore not be recommended.NCT02424461; Eudra-CT: 2013-001647-32.
Publication
Clinical Infectious Diseases
Date
2023-06-15
Volume
76
Issue
12
Pages
2154-2162
Journal Abbr
Clinical Infectious Diseases
Accessed
6/22/23, 2:04 PM
ISSN
1058-4838
Short Title
Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men
Library Catalog
Silverchair
Citation
Lafaurie, M., Chevret, S., Fontaine, J.-P., Mongiat-Artus, P., de Lastours, V., Escaut, L., Jaureguiberry, S., Bernard, L., Bruyere, F., Gatey, C., Abgrall, S., Ferreyra, M., Aumaitre, H., Aparicio, C., Garrait, V., Meyssonnier, V., Bourgarit-Durand, A., Chabrol, A., Piet, E., … for the PROSTASHORT Study Group. (2023). Antimicrobial for 7 or 14 Days for Febrile Urinary Tract Infection in Men: A Multicenter Noninferiority Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Clinical Infectious Diseases, 76(12), 2154–2162. https://doi.org/10.1093/cid/ciad070
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