FOsfomycin for Male Urinary Tract Infection

Prior treatment

• Acute retention of urine and indication for surgical or interventional drainage
• 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

Other illness

• No diagnosis of male urinary tract infection in the last 3 months,
• 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).
• Urinary tract infection associated with care, on urinary catheter or suprapubic catheter
• Severe disease or high probability of death within 3 months,
• Antibiotic taken within 72 hours of diagnosis of male urinary tract infection,
• Major cognitive impairment,
• 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.

Lab values

• 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),
• 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)

Other

• No ongoing chronic prostatitis,
• Hyperalgesic form
• Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship
• Known non-adherence to treatment,
• Simultaneous participation in another interventional clinical study,
• Cannot be taken orally (vomiting)

• 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