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 (1) , Sylvie Chevret (2) , Jean-Paul Fontaine (3) , Pierre Mongiat-Artus (4) , Victoire de Lastours (5) , Lélia Escaut (6) , Stéphane Jaureguiberry (6) , Louis Bernard (7) , Franck Bruyere (8) , Caroline Gatey (9) , Sophie Abgrall (10) , Milagros Ferreyra (10, 11) , Hugues Aumaitre (10, 11) , Caroline Aparicio (12) , Valérie Garrait (13) , Vanina Meyssonnier (14) , Anne Bourgarit-Durand (15) , Amélie Chabrol (16) , Emilie Piet (17) , Jean-Philippe Talarmin (18) , Marine Morrier (19) , Etienne Canoui (20) , Caroline Charlier (21) , Manuel Etienne (22) , Jerome Pacanowski (23) , Nathalie Grall (23) , Kristell Desseaux (24, 6) , Florence Empana-Barat (2) , Isabelle Madeleine (25) , Béatrice Bercot (26) , Jean-Michel Molina (27, 6) , Agnès Lefort (5)

1 Service de maladies infectieuses et tropicales [Saint-Louis]
2 Service de biostatistiques et information médicale [Saint-Louis]
3 AP-HP - Hopital Saint-Louis [AP-HP]
4 Service d'Urologie [CHU Saint-Louis]
5 Hôpital Beaujon [AP-HP]
6 IAME (UMR_S_1137 / U1137) - Infection, Anti-microbiens, Modélisation, Evolution
7 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
8 CHU Trousseau [Tours]
9 Service d'urologie [Tours]
10 Service de médecine interne, immunologie clinique [Béclère]
11 CESP - Centre de recherche en épidémiologie et santé des populations
12 Centre Hospitalier Saint Jean de Perpignan
13 Hôpital Lariboisière-Fernand-Widal [APHP]
14 CHI Créteil
15 Groupe Hospitalier Diaconesses Croix Saint-Simon
16 Hôpital Jean Verdier [AP-HP]
17 Centre Hospitalier Sud Francilien
18 Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
19 CHIC - Centre Hospitalier Intercommunal de Cornouaille
20 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
21 Service Maladies infectieuses et tropicales [AP-HP Hôpital Cochin]
22 Service des maladies infectieuses et tropicales [Rouen]
23 CHU Saint-Antoine [AP-HP]
24 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
25 AGEPS - Agence Générale des Equipements et Produits de Santé [Paris]
26 Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris]
27 Service de microbiologie [Saint-Louis]

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.

Domaines: Microbiologie et Parasitologie

Matthieu Lafaurie, Sylvie Chevret, Jean-Paul Fontaine, Pierre Mongiat-Artus, Victoire de Lastours, et al.. 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, 2023, ⟨10.1093/cid/ciad070⟩. ⟨hal-04034800⟩