Clinical trial NCT06822751: FOsfomycin for Male Urinary Tract Infection
Official title: Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Urinary Tract Infection
Prostatitis
Cystitis
Keywords: Men
Cystitis
Urinary Tract Infection
Anti-infective agents, urinary
Fosfomycin
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: INSERM UMR1311 DYNAMICURE
name: Department of General Practice, Rouen University
name: Health Ministry funding (ReSpiR funds)
First posted: 2025-02-12
Enrollment: 138
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Evaluate the efficacy of 14 days of fosfomycin trometamol (FT) treatment for non-febrile male urinary tract infections (MUTIs) in primary care
timeFrame: 14 days
Secondary outcomes:
measure: Nosological (clinical and biological) description of non-febrile male urinary tract infections (MUTIs) managed in primary care.
timeFrame: 3 months
measure: Clinical cure rate 10 to 12 weeks after inclusion (i.e., 8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment)
timeFrame: 8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment
measure: Microbiological cure rate (assessed by cytobacterial examination of urine), at 14 to 21 days and 10 to 12 weeks after inclusion.
timeFrame: at 14 to 21 days and 10 to 12 weeks after inclusion.
measure: Establishment of a repository of uropathogens responsible for MUTIs.
timeFrame: 3 months
measure: Analysis of treatment-related adverse effects, 14 days after inclusion
timeFrame: 14 days after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: University Rouen Hospital
name: Dr SOUDAIS, MD
role: PRINCIPAL_INVESTIGATOR
References: