FOsfomycin for Male Urinary Tract Infection

Phase 3Not Yet RecruitingNCT06822751

University Hospital, Rouen138 enrolled

Overview

Male urinary tract infections (MUTI) are often less recognised compared to those in women. French clinical guidelines practices recommend the use of antibiotics called fluoroquinolones, which are highly effective in treating MUTIs. However, these antibiotics can lead to rare but serious side effects, such as tendonitis or heart rhythm disturbances. Additionally, fluoroquinolones can contribute to the development of bacterial resistance, making their use inadvisable within six months of treatment. In response to these concerns, we aim to explore a well-established alternative, fosfomycin trometamol (known by the brand name MONURIL®). This antibiotic has a strong track record in treating UTIs in women, with well-documented benefits and minimal associated risks. The primary goal of this study is to assess the effectiveness of fosfomycin trometamol in treating urinary tract infections in men, as well as to evaluate any potential treatment failures.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Urinary Tract Infection Prostatitis Cystitis

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Evaluate the efficacy of 14 days of fosfomycin trometamol (FT) treatment for non-febrile male urinary tract infections (MUTIs) in primary care

The primary endpoint was defined as the absence of clinical failure up to 14 days after the end of antibiotic treatment. Failure is defined according to SPILF recommendations as : * a change of antibiotic treatment to a reference treatment (see above) for urinary tract infection ; * and/or hospitalisation for urinary tract infection ; * or/and acute retention of urine ; * or/and a new consultation for worsening or persistence of symptoms ; * or/and the appearance of a fever \> 38°C

Time frame: 14 days

Secondary Outcomes

Nosological (clinical and biological) description of non-febrile male urinary tract infections (MUTIs) managed in primary care.

Improvement in functional urinary symptomatology using a Lickert scale (1. Very unsignificant, 2. Unsignificant , 3. Neither , 4. Significant , 5. Very significant) , 2-5 days 28-35 days and 3 months after the start of treatment with FT;

Time frame: 3 months

Clinical cure rate 10 to 12 weeks after inclusion (i.e., 8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment)

cytobacteriological examination of the urine (CBEU) negative 10 to 12 weeks after the end of treatment ;

Time frame: 8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment

Microbiological cure rate (assessed by cytobacterial examination of urine), at 14 to 21 days and 10 to 12 weeks after inclusion.

Negative cytobacteriological examination of the urine (CBEU) (leucocyturia \< 10/mm3 OR leucocyturia \> 10/mm3 AND bacteriuria \< 103/mm3 or bacteriuria with a different pathogen) taken 14 to 21 days after the end of antibiotic treatment

Time frame: at 14 to 21 days and 10 to 12 weeks after inclusion.

Establishment of a repository of uropathogens responsible for MUTIs.

Regression of urinary signs 10 to 12 weeks after the end of treatment;

Time frame: 3 months

Analysis of treatment-related adverse effects, 14 days after inclusion

Adverse events presented by the patient and recorded by the investigating doctor during antibiotic treatment and in the 14 days following the end of treatment.

Time frame: 14 days after inclusion