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

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.

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: [e-mail].

Déclaration de conflit d'intérêts

Potential conflicts of interest. A. B.-D. reports ongoing fees for a Gilead lecture on tuberculosis in December 2022 and an unpaid role as the president of the French professional comity of internal medicine. F. B. reports payment or honoraria for a lecture for Karopharma, support for meeting by Janssen, participation on an advisory board for Eumedica, and role as member of the administration group of the French Association of Urology. M. E. reports honoraria for speaker’s bureau from MSD (October 2022) and invitation to meeting from Pfizer (3 October 2021). J.-M. M. reports grants or contracts from Gilead Sciences to institution; consulting fees paid to author from Gilead, ViiV, and Merck advisory boards; and payment for participation on a data and safety monitoring board (DSMB) or advisory board from Aelix. S. J. reports participation on the Artemis project DSMB. P. M.-A. reports personal consulting fees and support for attending meetings and/or travel from Bayer; personal fees for lectures, presentations, speaker’s bureaus, manuscript writing, educational events, and participation on a DSMB or advisory board from Ferring; and unpaid leadership or fiduciary roles for Association Française d’Urologie, Conseil National Professionnel d’Urologie, and Agence de la Bio-Medecine. J.-P. T. reports support for attending meetings and/or travel for Gilead and Pfizer. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.