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Randomized, Multicenter, Non-inferiority Trial Comparing the Efficacy of Fosfomycin Versus Fluoroquinolones or Cotrimoxazole as Oral Follow-up Treatment in Febrile Urinary Tract Infections in Men Caused by Susceptible Enterobacteria (FOSFORMEN)

2026年11月5日 更新者:Assistance Publique - Hôpitaux de Paris

Essai randomisé, Multicentrique, de Non-infériorité Comparant l'efficacité d'un Traitement Par Fosfomycine Versus Fluoroquinolones ou Cotrimoxazole en Relais Oral Dans Les Infections Urinaires Masculines fébriles Dues à Escherichia Coli

The fosfomycin-trometamol (FT) combination demonstrates microbiological efficacy against the vast majority of Escherichia coli strains responsible for urinary tract infections (UTIs). Moreover, approximately 99% of strains exhibiting multidrug resistance remain suceptible to fosfomycin.

The clinical tolerance profile of this molecule is excellent and has been well established since its market authorization in 1989 for the treatment of cystitis in women.

Its pharmacokinetic and pharmacodynamic properties are compatible with its use in the treatment of UTIs in men.

However, the clinical efficacy of FT (oral fosfomycin) in the treatment of febrile UTIs in men has never been evaluated in prospective trials. FT could represent an innovative treatment option in such cases, offering the use if an antibiotic with significantly fewer side effects than those currently recommended.

The main objective of the trial is to demonstrate that FT is not inferior to fluoroquinolones (FQ) or cotrimoxazole (TMP-SMX) as oral step-down therapy in prostatitisfebrile male urinary tract infections caused by Escherichia coli.

研究概览

研究类型

介入性

注册 (估计的)

312

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Male
  • Age ≥ 18
  • Body temperature ≥ 38°C within the 72 hours preceding the diagnosis of UTI
  • At least one of the following symptoms : dysuria, higher urinary frequency, urgency, hematuria, suprapubic pain, prostatic pain, or perineal pain
  • Positive urine microbiological examination (urine culture) : Sample collected before initiation of the empiric antibiotic therapy, ≥ 10 leukocytes/µL, and monomicrobial culture positive for E. coli with bacteriuria ≥ 103 CFU/mL
  • The strain must be suceptible to fosfomycin and to either FQ or TMP-SMX according to EUCAST
  • The strain must be suceptible to the empiric antibiotic therapy received
  • Ability to take oral treatment
  • Favorable clinical evolution after receiving effective empiric antibiotic therapy for 72 ± 24 hours ; Favorable evolution is defined as body temperature < 38°C with clinical improvement or resolution of the clinical signs and symptoms of urinary tract infection present at diagnosis, including the absence or improvement of dysuria, pollakiuria, urinary urgency, hematuria, suprapubic, prostatic, or perineal pain, urethral pain during urination, and/or a burning sensation during urination.

Exclusion Criteria:

  • Presence of another condition that could explain the fever
  • Septic shock of urinary origin
  • Need for a urological procedure
  • Anatomical abnormalities of the urinary tract (e.g., urinary prostheses and implants [except JJ], Bricker, neobladder, total prostatectomy, uretrestomy, nephrostomy, urinary fistula)
  • Presence of an indwelling urinary catheter, except of placed during the current UTI episode
  • Neurogenic bladder
  • Immunosupression
  • Contraindication to the use of FQ , TMP-SMX or FT
  • Severe chronic kidney disease with an estimated flomerular filtration rate < 20 mL/min
  • UTI treated within the past 3 months
  • High probability of death within 3 months
  • Major cognitive disorders
  • Patients deprived of their liberty by judicial or administrative decision, under guardianship or curatorship
  • Lack of social security coverage
  • Absence of written informed consent
  • Participation in another interventional research protocol
  • Absence of written informed consent
  • Participation in another interventional research protocol
  • Patients deprived of their liberty by a judicial or administrative decision

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Fosfomycin-trometamol (FT)

Oral dose : 3g Fosfomycin-trometamol once daily

有源比较器:Reference treatments as per the French SPLIF guidlines

Reference treatments will bet hose recommended by the French SPLIF guidlines :

  • Oral FQ : three molecules are authorized ; ofloxacin, ciprofloxacin and levofloxacin
  • TMP-SMX

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Clinical cure
大体时间:At day 26

Defined as body temperature < 38°C and absence of urinary tract infection symptoms, without the need for additional antibiotic therapy up to the primary evaluation on Day 26, which corresponds to 14 days after completion of a 12-day antibiotic treatment assigned by randomization.

At day 26

次要结果测量

结果测量
措施说明
大体时间
Cumulative incidence of infectious and urological complications
大体时间:Up to day 40
Up to day 40
Adherence to treatment
大体时间:Up to day 40
Up to day 40
Occurence of adverse events related to anticiotics
大体时间:Up to day 40

Occurrence, nature, and severity of adverse events

Up to day 40
Rectal carriage of phenotypically antibiotic-resistant Enterobacterales
大体时间:At day 26

Carriage of Enterobacterales resistant to FQ, TMP-SMX, fosfomycin, and third-generation cephalosporins on Day 26, i.e., 14 days after completion of the randomized antibiotic treatment Binary outcome

At day 26
Rates of recurrence of febrile or non-febrile UTIs (relapse or reinfection)
大体时间:At day 40

Assessed on Day40, i.e., 28 days after completion of the randomized antibiotic treatment

  • UTI : reappearance of urinary symptoms with a positive urine culture (ECBU)
  • Febrile UTI : fever or urinary origin with a positive urine culture
  • Relapse : new infection caused by the same bacteria than as the initial episode
  • Reinfection : new infection caused by a different bacteria than the initial episode
At day 40
Number of patients who experienced treatment failure
大体时间:Up to day 40

Clinical and biological characteristics of patients who experienced treatment failure compared to those who were cured during the initial episode

Up to day 40

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2029年12月26日

研究完成 (估计的)

2030年1月15日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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