Viewing Study NCT06822751


Ignite Creation Date: 2025-12-24 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
Study NCT ID: NCT06822751
Status: NOT_YET_RECRUITING
Last Update Posted: 2025-02-19
First Post: 2025-01-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: FOsfomycin for Male Urinary Tract Infection
Sponsor: University Hospital, Rouen
Organization:

Study Overview

Official Title: Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care
Status: NOT_YET_RECRUITING
Status Verified Date: 2025-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FOMUTI
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 MONURILĀ®). 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
2023-510355-36-00 CTIS None View