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

被引：1

作者：

Lafaurie, Matthieu ^{[1
,33
]}

Chevret, Sylvie ^{[2
,3
]}

Fontaine, Jean-Paul ^{[4
]}

Mongiat-Artus, Pierre ^{[5
]}

de Lastours, Victoire ^{[6
,7
,8
]}

Escaut, Lelia ^{[9
]}

Jaureguiberry, Stephane ^{[9
]}

Bernard, Louis ^{[10
]}

Bruyere, Franck ^{[11
]}

Gatey, Caroline ^{[12
,15
]}

Abgrall, Sophie ^{[13
]}

Ferreyra, Milagros ^{[14
]}

Aumaitre, Hugues ^{[14
]}

Aparicio, Caroline

Garrait, Valerie ^{[16
]}

Meyssonnier, Vanina ^{[17
]}

Bourgarit-Durand, Anne ^{[18
]}

Chabrol, Amelie ^{[19
]}

Piet, Emilie ^{[20
]}

Talarmin, Jean-Philippe ^{[21
]}

Morrier, Marine ^{[22
]}

Canoui, Etienne ^{[23
]}

Charlier, Caroline ^{[23
,24
]}

Etienne, Manuel ^{[25
]}

Pacanowski, Jerome ^{[26
]}

Grall, Nathalie ^{[7
,8
,27
]}

Desseaux, Kristell ^{[28
]}

Empana-Barat, Florence ^{[29
]}

Madeleine, Isabelle ^{[30
]}

Bercot, Beatrice ^{[7
,8
,31
]}

Molina, Jean-Michel ^{[32
]}

Lefort, Agnes ^{[6
,7
,8
]}

机构：

[1] Hop St Louis, Hop Lariboisiere, AP HP, Dept Infect Dis, Paris, France

[2] Hop St Louis, Dept Biostat, AP HP, Paris, France

[3] Univ Paris Diderot, Inserm S 717, Paris, France

[4] Hop St Louis, Emergency Dept, AP HP, Paris, France

[5] Hop St Louis, AP HP, Dept Urol, Paris, France

[6] Hop Beaujon, AP HP, Dept Internal Med, Clichy, France

[7] Univ Paris Cite, Infect Antimicrobials Modelling Evolut IAME Res Gr, UMR 1137, Paris, France

[8] Inserm, Paris, France

[9] Hop Bicetre, Dept Infect Dis, AP HP, Le Kremlin Bicetre, France

[10] CHRU Tours, Dept Infect Dis, Tours, France

[11] CHRU Tours, Dept Urol, Tours, France

[12] Hop Antoine Beclere, AP HP, Dept Internal Med, Clamart, France

[13] Univ Paris Saclay, Inserm, U1018, Le Kremlin Bictre, France

[14] Ctr Hosp Perpignan, Dept Infect Dis, Perpignan, France

[15] Hop Lariboisiere, AP HP, Dept Internal Med, Paris, France

[16] Ctr Hosp Intercommunal Creteil, Dept Internal Med, Creteil, France

[17] Grp Hosp Diaconesses Croix St Simon, Dept Internal Med & Infect Dis, Paris, France

[18] Hop Jean Verdier, AP HP, Dept Internal Med, Bondy, France

[19] Hop Sud Francilien, Dept Infect Dis, Corbeil Essonnes, France

[20] Ctr Hosp Annecy Genevois, Dept Infect Dis, Annecy, France

[21] Ctr Hosp Intercommunal Cornouaille, Dept Infect Dis, Quimper, France

[22] Ctr Hosp Dept La Roche Sur Yon, Dept Infect Dis, La Roche Sur Yon, France

[23] Hop Cochin, AP HP, Mobile Infect Dis Team, Paris, France

[24] Univ Paris Cite Hosp, AP HP, French Natl Reference Ctr Listeria, Inst Pasteur,Biol Infect Unit,Inserm,U1117, Paris, France

[25] Hop Charles Nicolle, Dept Infect Dis, Rouen, France

[26] Hop St Antoine, Dept Infect Dis, AP HP, Paris, France

[27] Hop Bichat Claude Bernard, Dept Bacteriol, AP HP, Paris, France

[28] Hop St Louis, Dept Biostat, AP HP, Paris, France

[29] Agence Gen Equipements & Prod St, Clin Trial Dept, AP, Paris, France

[30] Hop St Louis, Pharm, AP HP, Paris, France

[31] Hop St Louis, Hop Lariboisiere, Dept Microbiol, AP HP, Paris, France

[32] Univ Paris Cite, Inserm, UMR 941, Paris, France

[33] Hop St Louis, Infect Dis Dept, 1 Ave Claude Vellefaux, F-75010 Paris, France

来源：

CLINICAL INFECTIOUS DISEASES | 2023年 / 76卷 / 12期

关键词：

urinary tract infection; men; antibiotic duration; ofloxacin; ANTIBIOTIC-TREATMENT; DURATION;

D O I：

暂无

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

In this multicenter randomized, double-blind placebo-controlled noninferiority trial, 240 men were assigned to receive antibiotic therapy for 7 (115 participants) or 14 days (125 participants) for febrile urinary tract infection. A treatment for 7 days was inferior to 14 days. 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.

引用

页码：2154 / 2162

页数：9