Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 28
- 主要终点
- Evaluate the efficacy of 14 days of fosfomycin trometamol (FT) treatment for non-febrile male urinary tract infections (MUTIs) in primary care
研究概览
简要总结
Male urinary tract infections (MUTI) are often less recognised compared to those in women. French clinical guidelines practices recommend the use of antibiotics called fluoroquinolones, which are highly effective in treating MUTIs. However, these antibiotics can lead to rare but serious side effects, such as tendonitis or heart rhythm disturbances. Additionally, fluoroquinolones can contribute to the development of bacterial resistance, making their use inadvisable within six months of treatment.
In response to these concerns, we aim to explore a well-established alternative, fosfomycin trometamol (known by the brand name MONURIL®). This antibiotic has a strong track record in treating UTIs in women, with well-documented benefits and minimal associated risks.
The primary goal of this study is to assess the effectiveness of fosfomycin trometamol in treating urinary tract infections in men, as well as to evaluate any potential treatment failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 years or older.
- •Consulting in a primary care setting.
- •Suspected of having a male urinary tract infection (MUTI) by the investigating physician and presenting at least one recent acute symptom (< 3 months) from the following:
- •Lower urinary tract symptoms: dysuria, urgency, frequency, hematuria.
- •Pelvic pain unrelated to urination: suprapubic, perineal, or urethral pain.
- •Patient has read and understood the information letter and signed the informed consent form.
- •Affiliation with a social security system or beneficiary of such a system.
- •No history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed consent
排除标准
- •Presence of one or more criteria for severity of infection
- •Severe sepsis or septic shock defined by a qSOFA score ≥ 2
- •or/and systolic BP less than 100 mmHg: non-inclusion criterion
- •or/and temperature < 36°C or > 38°C
- •or/and diagnosis of pyelonephritis (pain on lumbar percussion)
- •or/and presence of abdominal guarding/contraction
- •or/and presence of a bladder globe above the pubic bone: (suspected acute retention of urine)
- •or/and known immunosuppression: any immunosuppressive treatment (including corticosteroid therapy > 10 mg/d for more than 5 days), neutropenia (PNN < 500/mL) severe malnutrition (albumin < 30 and/or BMI < 16),
- •No diagnosis of male urinary tract infection in the last 3 months,
- •No ongoing chronic prostatitis,
- •Known urinary tract abnormality: urinary tract lithiasis, vesico-ureteral reflux, prostate or urinary tract cancer, prostate adenoma treated medically or surgically, urinary tract malformation (including single kidney and urethral stricture).
- •Acute retention of urine and indication for surgical or interventional drainage
- •Hyperalgesic form
- •Urinary tract infection associated with care, on urinary catheter or suprapubic catheter
- •Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation less than 3 months old
- •Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation less than 3 months old
- •Severe disease or high probability of death within 3 months,
- •Hypersensitivity to fosfomycin trometamol or to any of the excipients (notable excipients: sucrose, dextrose (source of glucose), maltodextrin (source of glucose), orange yellow colouring S (E110)),
- •End-stage renal disease (creatinine clearance <10 mL/min),
- •Patients with glucose and galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disease)
- •Antibiotic taken within 72 hours of diagnosis of male urinary tract infection,
- •Major cognitive impairment,
- •Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship
- •Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent the subject from giving informed consent.
- •Known non-adherence to treatment,
- •Simultaneous participation in another interventional clinical study,
- •Cannot be taken orally (vomiting)
研究组 & 干预措施
fosfomycine-trometamol
Single-Arm The treatment studied is fosfomycin trometamol (FT): FOSFOMYCINE ARROW ADULTS 3 g, granule for drinkable solution in sachet.
FT is available in generic form. It comes in a sachet of 3 g of granules for oral solution (orange flavour).
In this study, FT will be taken to treat a non-febrile male urinary tract infection, at a dosage of 3 g per day every 2 days for 14 days, i.e. 7 doses (D0, D2, D4, D6, D8, D10, D14). Seven sachets, accompanied by a prescription specifying the dosage, will therefore be given to the patient on inclusion in the study.
干预措施: Fosfomycun-trometamol (Drug)
结局指标
主要结局
Evaluate the efficacy of 14 days of fosfomycin trometamol (FT) treatment for non-febrile male urinary tract infections (MUTIs) in primary care
时间窗: 14 days
The primary endpoint was defined as the absence of clinical failure up to 14 days after the end of antibiotic treatment. Failure is defined according to SPILF recommendations as : * a change of antibiotic treatment to a reference treatment (see above) for urinary tract infection ; * and/or hospitalisation for urinary tract infection ; * or/and acute retention of urine ; * or/and a new consultation for worsening or persistence of symptoms ; * or/and the appearance of a fever \> 38°C
次要结局
- Nosological (clinical and biological) description of non-febrile male urinary tract infections (MUTIs) managed in primary care.(3 months)
- Clinical cure rate 10 to 12 weeks after inclusion (i.e., 8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment)(8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment)
- Microbiological cure rate (assessed by cytobacterial examination of urine), at 14 to 21 days and 10 to 12 weeks after inclusion.(at 14 to 21 days and 10 to 12 weeks after inclusion.)
- Establishment of a repository of uropathogens responsible for MUTIs.(3 months)
- Analysis of treatment-related adverse effects, 14 days after inclusion(14 days after inclusion)