Health TrialsbyHealthPanel

FOsfomycin for Male Urinary Tract Infection

ConditionsUrinary Tract InfectionProstatitisCystitis
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Fosfomycun-trometamol

    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.

Treatment groups

138 Participants
are divided into 1 treatment group
Group A: fosfomycine-trometamolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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.
4

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

Other outcomes

Sponsors and contacts

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University Hospital, Rouen

Lead sponsor

INSERM UMR1311 DYNAMICURE

Collaborator

Department of General Practice, Rouen University

Collaborator

Health Ministry funding (ReSpiR funds)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: