ELBEUF
Elbeuf, 76500, France
Location contact
Benjamin Soudais, Dr
CONTACT
Benjamin Soudais, Dr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06822751
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.
Trial opening soon.
Get Notified18 year and older
Male
Interventional
Phase 3
Elbeuf, 76500, France
Benjamin Soudais, Dr
CONTACT
Benjamin Soudais, Dr
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 14 days
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 :
Time frame: 3 months
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: 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: 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: 3 months
Regression of urinary signs 10 to 12 weeks after the end of treatment;
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Dr SOUDAIS, MD
CONTACT
Mylene HERVET
CONTACT
University Hospital, Rouen
Other
Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care
Acronym: FOMUTI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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