FOsfomycin for Male Urinary Tract Infection

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

Qualifiers

Men aged 18 years or older.

Consulting in a primary care setting.

Lower urinary tract symptoms: dysuria, urgency, frequency, hematuria.

Pelvic pain unrelated to urination: suprapubic, perineal, or urethral pain.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fosfomycun-trometamol

Treatment groups

138 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Rouen

Lead sponsor

INSERM UMR1311 DYNAMICURE

Collaborator

Department of General Practice, Rouen University

Collaborator

Health Ministry funding (ReSpiR funds)

Collaborator