FOsfomycin for Male Urinary Tract Infection

NCT ID: NCT06822751

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-09-30

Brief Summary

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.

Conditions

Urinary Tract Infection; Prostatitis; Cystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fosfomycine-trometamol

Single-Arm The treatment studied is fosfomycin trometamol (FT): FOSFOMYCINE ARROW ADULTS 3 g, granule for drinkable solution in sachet.

FT is available in generic form. It comes in a sachet of 3 g of granules for oral solution (orange flavour).

In this study, FT will be taken to treat a non-febrile male urinary tract infection, at a dosage of 3 g per day every 2 days for 14 days, i.e. 7 doses (D0, D2, D4, D6, D8, D10, D14). Seven sachets, accompanied by a prescription specifying the dosage, will therefore be given to the patient on inclusion in the study.

Group Type: EXPERIMENTAL

Fosfomycun-trometamol

Intervention Type: DRUG

Study of the efficacy and safety of Fosfomycin trometamol as a 14-day treatment using a 3 g sachet every 2 days for 14 days for the treatment of male urinary tract infections in primary care: open-label, non-randomised, multicentre, inter-regional trial.

Interventions

Fosfomycun-trometamol

Study of the efficacy and safety of Fosfomycin trometamol as a 14-day treatment using a 3 g sachet every 2 days for 14 days for the treatment of male urinary tract infections in primary care: open-label, non-randomised, multicentre, inter-regional trial.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

INSERM UMR1311 DYNAMICURE

UNKNOWN

Sponsor Role: collaborator

Department of General Practice, Rouen University

UNKNOWN

Sponsor Role: collaborator

Health Ministry funding (ReSpiR funds)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr SOUDAIS, MD

Role: PRINCIPAL_INVESTIGATOR

University Rouen Hospital

Central Contacts

Dr SOUDAIS, MD

Role: CONTACT

benjaminsoudais@univ-rouen.fr

+33023577013

Mylene HERVET

Role: CONTACT

mylene.hervet@chu-rouen.fr

+330232888265

Other Identifiers

2023-510355-36-00

Identifier Type: CTIS

Identifier Source: secondary_id

2021/0376/HP

Identifier Type: -

Identifier Source: org_study_id