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 - Tập 76 Số 12 - Trang 2154-2162 - 2023
Matthieu Lafaurie1, Sylvie Chevret2, Jean-Paul Fontaine3, P. Mongiat-Artus4, Victoire de Lastours5,6, L. Escaut7, Éric Caumes7, Louis Bernard8, F. Bruyére9, Caroline Gatey10, Sophie Abgrall11, Milagros Ferreyra12, Hugues Aumaître12, C. Aparicio13, Valérie Garrait14, Vanina Meyssonnier15, A. Bourgarit-Durand16, Amélie Chabrol17, E. Piet18, Jean–Philippe Talarmin19, Marine Morrier20, Etienne Canouï21, Caroline Charlier22,23, Manuel Etienne24, Jérôme Pacanowski25, Nathalie Grall26,6, Kristell Desseaux27, Florence Empana-Barat28, Isabelle Madeleine29, Béatrice Berçot30,6, Jean‐Michel Molina31, A. Lefort5,6, Carlo Giaquinto7, Isabelle Madelaine, S. Olivé, Albert Sotto, Pierre Tattevin4, Esther Simon-Libchaber, Giovanna Melica, R. Lepeule, Sophie Alviset11, Nicolas Fortineau, F. Roblot, V. Delcey, Romain Dufau, Aurélien Dinh, Alejandro Martín‐Quirós, G. Gavazzi, Marie‐Charlotte Chopin, Arthur Lehel, Nabil Raked, Cécile Kedzia, Stéphane Lo28, Romain Bricca, Gilles Dumondin, X. Lemaire
1Department of Infectious Diseases, Hôpital Saint-Louis-Hôpital Lariboisière, Assistance Publique–Hôpitaux de Paris (AP-HP) , Paris , France
2Department of Biostatistics, Hôpital Saint-Louis, AP-HP, Paris, France; Université Paris Diderot, Inserm S 717
3Emergency Department, Hôpital Saint-Louis, AP-HP, Paris, France
4Department of Urology, Hôpital Saint-Louis, AP-HP , Paris , France
5Department of Internal Medicine, Hôpital Beaujon, AP-HP, Clichy, France
6Infection Antimicrobials Modelling Evolution (IAME) Research Group , UMR 1137, Université Paris Cité et Inserm, Paris , France
7Department of Infectious Diseases, Hôpital de Bicêtre, AP-HP , Le Kremlin-Bicêtre , France
8Department of Infectious Diseases , Centre Hospitalier Régional Universitaire de Tours, Tours , France
9Department of Urology, Centre Hospitalier Régional Universitaire de Tours, Tours , France
10Department of Internal Medicine, Hôpital Antoine Béclère, AP-HP , Clamart , France
11Université Paris-Saclay, Inserm U1018, Le Kremlin-Bićtre, France
12Department of Infectious Diseases, Centre Hospitalier de Perpignan , Perpignan , France
13Department of Internal Medicine, Hôpital Lariboisière, AP-HP , Paris , France
14Department of Internal Medicine, Centre Hospitalier Intercommunal de Créteil, Créteil, France
15Department of Internal Medicine and Infectious Diseases, Groupe Hospitalier Diaconesses Croix Saint-Simon , Paris , France
16Department of Internal Medicine, Hôpital Jean Verdier, AP-HP , Bondy , France
17Department of Infectious Diseases, Hôpital Sud Francilien , Corbeil-Essonnes , France
18Department of Infectious Diseases, Centre Hospitalier Annecy Genevois , Annecy , France
19Department of Infectious Diseases, Centre Hospitalier Intercommunal de Cornouaille , Quimper , France
20Department of Infectious Diseases, Centre Hospitalier Départemental de la Roche sur Yon , La Roche sur Yon , France
21Mobile Infectious Diseases Team, Hôpital Cochin, AP-HP , France
22French National Reference Center Listeria, Biology of Infection Unit, Inserm U1117, Institut Pasteur, France
23Université Paris-Cité Hospital, AP-HP; French National Reference Center Listeria, Biology of Infection Unit, Inserm U1117, Institut Pasteur , France
24Department of Infectious Diseases, Hôpital Charles Nicolle , Rouen , France
25Department of Infectious Diseases, Hôpital Saint-Antoine, AP-HP , Paris , France
26Department of Bacteriology, Hôpital Bichat, AP-HP , Paris , France
27Department of Biostatistics, Hôpital Saint-Louis, AP-HP , Paris , France
28Clinical Trial Department, Agence Générale des Équipements et Produits de Santé, AP-, Paris, France
29Pharmacy, Hôpital Saint-Louis, AP-HP , Paris , France
30Department of Microbiology, Hôpital Saint-Louis-Hôpital Lariboisière, AP-HP , Paris , France
31Department of Infectious Diseases, Hôpital Saint-Louis-Hôpital Lariboisière, AP-HP, Paris, France; Université Paris Cité, Inserm UMR 941 , Paris , France

Tóm tắt

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.

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Clinical Infectious Diseases

Tập 76 Số 12

2154-2162

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