FOsfomycin for Male Urinary Tract Infection

Launched by UNIVERSITY HOSPITAL, ROUEN · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of an antibiotic called fosfomycin trometamol (known as MONURIL®) for treating urinary tract infections (UTIs) in men. UTIs in men are often overlooked, and the usual treatment with fluoroquinolone antibiotics can have serious side effects and contribute to antibiotic resistance. The goal of this study is to see if fosfomycin trometamol can be a safer and effective alternative for men with UTIs.

To be eligible for this trial, participants must be men aged 18 or older who have symptoms of a urinary tract infection, such as painful urination or pelvic pain. They should not have any severe health issues or a recent history of UTIs that could complicate their treatment. If eligible, participants will receive treatment with fosfomycin and will be monitored for how well the antibiotic works and if there are any treatment failures. It's important to note that this trial is not yet recruiting participants, but it aims to find a safer option for managing male urinary tract infections.

Gender

MALE

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)