2026-525972-25-00招募中3 期
FOSFORMEN : 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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 20
- 主要终点
- The primary endpoint will be a binary outcome, defined as clinical cure (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.
研究概览
简要总结
To demonstrate that the fosfomycin-trometamol (FT) combination is not inferior to fluoroquinolones (FQ) or cotrimoxazole (TMP-SMX) as oral step-down therapy in febrile male urinary tract infections caused by Escherichia coli.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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, flank 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 of urinary tract infection signs and symptomps present at diagnosis
排除标准
- •Presence of another condition that could explain the fever
- •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
- •Individuals depreived of liberty by juriducal or administrative decision
- •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
结局指标
主要结局
The primary endpoint will be a binary outcome, defined as clinical cure (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.
The primary endpoint will be a binary outcome, defined as clinical cure (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.
次要结局
- To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) the cumulative incidence of infectious and urological complications
- To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) adherence to treatment, occurrence, nature, and severity of adverse events related to antibiotics
- To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) rectal carriage of phenotypically antibiotic-resistant Enterobacterales (resistant to FQ, TMP-SMX, fosfomycin, and thired-generation cephalosporins) on Day 26, i.e., 14 days after completion of the randomized antibiotic treatment
- To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) rates of recurrence of febrile or non-febrile UTIs (relapse or reinfection), assessed on Day40, i.e., 28 days after completion of the randomized antibiotic treatment
- To compare between the two groups (experimental treatment : oral FT vs. Standard treatment : oral FQ or oral TMP-SMX) analysis of clinical and biological characteristics of patients who experienced treatment failure compared to those who were cured during the initial episode.
研究者
Dr Antoine HAMON
Scientific
Assistance Publique Hopitaux De Paris
研究点 (20)
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