FOSFOMYCIN TROMETAMOL for Male urinary tract infection

Inclusion criteria

• {"criterion_text":"- Men aged 18 and over"}
• {"criterion_text":"- Consultant patient in a general practice"}
• {"criterion_text":"- Suspected of MUI by their investigating physician AND presenting at least one recent acute sign (< 3 months) from among the following: - functional urinary signs: urinary burning, urgency, pollakiuria, dysuria, haematuria - pelvic pain independent of micturition: suprapubic, perineal, urethral"}
• {"criterion_text":"- Patient has read and understood the information letter and signed the consent form"}
• {"criterion_text":"- Membership of a social security scheme or beneficiary of such a scheme"}
• {"criterion_text":"- Patient unable to understand the conditions required for participation in the protocol or unable to give informed consent"}

Exclusion criteria

• {"criterion_text":"- Presence of one or more infection severity criteria: - Severe sepsis or septic shock defined by a qSOFA score ≥ 2 - or/and systolic BP below 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 suprapubic vesical globe: (suspicion of acute urine retention) - or/and known immunosuppression: any immunosuppressive treatment (including corticosteroid therapy > 10 mg/d for more than 5 days), neutropenia (PNN < 500/mL) severe undernutrition (Albumin < 30 and/or BMI < 16),"}
• {"criterion_text":"- Severe illness or high probability of death within 3 months"}
• {"criterion_text":"- 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))."}
• {"criterion_text":"- End-stage renal disease (creatinine clearance <10 mL/min)"}
• {"criterion_text":"- Patients with glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disease)."}
• {"criterion_text":"- Antibiotics taken within 72 hours of diagnosis of male urinary tract infection"}
• {"criterion_text":"- Major cognitive disorders"}
• {"criterion_text":"- Persons deprived of their liberty by an administrative or judicial decision or guardianship persons placed under guardianship with representation relating to the person, persons placed under a mandate for future protection, persons benefiting from family habilitation, persons under guardianship, persons under court protection"}
• {"criterion_text":"- History of psychological or sensory illness or abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or from giving informed consent."}
• {"criterion_text":"- Known non-compliance with medication"}
• {"criterion_text":"- Simultaneous participation in another clinical intervention study"}
• {"criterion_text":"- No diagnosis of male urinary tract infection in the last 3 months"}
• {"criterion_text":"- Oral treatment not possible (vomiting)."}
• {"criterion_text":"- No ongoing chronic prostatitis"}
• {"criterion_text":"- Known urinary tract anomaly: urinary tract lithiasis, vesicoureteral reflux, prostate or urinary tract cancer, medically or surgically treated prostate adenoma, urinary tract malformation (including single kidney and urethral stricture)"}
• {"criterion_text":"- Acute urine retention and indication for surgical or interventional drainage"}
• {"criterion_text":"- Hyperalgesic form"}
• {"criterion_text":"- Care-associated urinary tract infection on urinary catheter or suprapubic catheter"}
• {"criterion_text":"- Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterization less than 3 months old"}
• {"criterion_text":"- Urethral discharge or context suggestive of sexually transmitted infection"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint was defined as the absence of clinical treatment failure up to 14 days after the end of antibiotic treatment. Failure is defined according to SPILF recommendations by : - a change of antibiotic treatment to a reference treatment (see above) for urinary tract infection ; - or/and hospitalization for urinary tract infection ; - or/and acute retention of urine ; - or/and a new consultation for worsening or persistence of symptoms ; - or/and onset of fever > 38°C","definition_or_measurement_approach":"Absence of clinical treatment failure up to 14 days after end of antibiotic treatment. Failure is defined per SPILF recommendations as any of: change to a reference antibiotic treatment for UTI, hospitalization for UTI, acute urinary retention, new consultation for worsening/persistent symptoms, or onset of fever > 38°C."}

Secondary endpoints

• {"endpoint_text":"- Improvement in functional urinary symptomatology, 2-5 days 28-35 days and 3 months after the start of treatment with FT","definition_or_measurement_approach":"Assessment of improvement in functional urinary symptoms at 2-5 days, 28-35 days and 3 months after treatment start (timed clinical symptom assessments)."}
• {"endpoint_text":"- Negative ECBU 10 to 12 weeks after end of treatment","definition_or_measurement_approach":"Urine cytobacteriological examination (ECBU) reported as negative 10–12 weeks after end of treatment."}
• {"endpoint_text":"- negative ECBU (leukocyturia < 10/mm3 OR leukocyturia > 10/mm3 AND bacteriuria < 103/mm3 or bacteriuria with a different pathogen) taken 14 to 21 days after the end of antibiotic treatment","definition_or_measurement_approach":"ECBU result at 14–21 days post-treatment defined negative by specified leukocyturia/bacteriuria thresholds or different pathogen."}
• {"endpoint_text":"- Regression of urinary signs 10 to 12 weeks after the end of treatment","definition_or_measurement_approach":"Clinical assessment of regression of urinary signs at 10–12 weeks post-treatment."}
• {"endpoint_text":"- Adverse events reported by the patient and recorded by the investigating physician during antibiotic treatment and in the 14 days following the end of treatment","definition_or_measurement_approach":"Recording of patient-reported adverse events during treatment and for 14 days after treatment end, as collected by the investigator."}

Methods

• Recruitment in primary care: patients consulting general practitioners at listed French primary care sites (general practice / maison de santé / cabinet médical); target audience adult men with suspected male urinary tract infection.

France

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

25

Number Of Sites

32

Number Of Participants

110

Primary sponsor

Full Name

CHU De Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France