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Exploratory Pragmatic trial of fosfomycin-trometamol treatment of male urinary tract infections in primary care.
EU CTIS ID: 2023-510355-36-00
What this study is testing
Evaluation of the efficacy of sequential treatment with Fosfomycin Trometamol (FT) for 14 days
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men aged 18 and over
- Consultant patient in a general practice
- 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
- Patient has read and understood the information letter and signed the consent form
- Membership of a social security scheme or beneficiary of such a scheme
- Patient unable to understand the conditions required for participation in the protocol or unable to give informed consent
You likely can't join if
- 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),
- Severe illness 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-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disease).
- Antibiotics taken within 72 hours of diagnosis of male urinary tract infection
See the full eligibility criteria
Who can join
- Men aged 18 and over
- Consultant patient in a general practice
- 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
- Patient has read and understood the information letter and signed the consent form
- Membership of a social security scheme or beneficiary of such a scheme
- Patient unable to understand the conditions required for participation in the protocol or unable to give informed consent
What rules you out
- 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),
- Severe illness 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-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disease).
- Antibiotics taken within 72 hours of diagnosis of male urinary tract infection
- Major cognitive disorders
- 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
- 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.
- Known non-compliance with medication
- Simultaneous participation in another clinical intervention study
- No diagnosis of male urinary tract infection in the last 3 months
- Oral treatment not possible (vomiting).
- No ongoing chronic prostatitis
- 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)
- Acute urine retention and indication for surgical or interventional drainage
- Hyperalgesic form
- Care-associated urinary tract infection on urinary catheter or suprapubic catheter
- Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterization less than 3 months old
- Urethral discharge or context suggestive of sexually transmitted infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.