FOsfomycin for Male Urinary Tract Infection

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 investigatingphysician and presenting at least one recent acute symptom (< 3 months) from thefollowing:

• 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 informedconsent 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 thesubject from fully understanding the conditions required for participation in theprotocol 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 acuteretention of urine)

• or/and known immunosuppression: any immunosuppressive treatment (includingcorticosteroid 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 suprapubiccatheter

• Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation lessthan 3 months old

• Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation lessthan 3 months old

• Severe disease or high probability of death within 3 months,

• Hypersensitivity to fosfomycin trometamol or to any of the excipients (notableexcipients: 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/isomaltasedeficiency (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 personplaced under court protection / sub- guardianship or curatorship

• Any history of illness or psychological or sensory abnormality likely to prevent thesubject from fully understanding the conditions required for participation in theprotocol 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)