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Exploratory Pragmatic trial of fosfomycin-trometamol treatment of male urinary tract infections in primary care.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510355-36-00
Acronym
2021/0376/HP
Enrollment
110
Registered
2024-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Urinary Tract Infection

Brief summary

The primary endpoint was defined as the absence of clinical treatment failure up to 14 days after the end of antibiotic treatment. Failure is defined according to SPILF recommendations by : - a change of antibiotic treatment to a reference treatment (see above) for urinary tract infection ; - or/and hospitalization for urinary tract infection ; - or/and acute retention of urine ; - or/and a new consultation for worsening or persistence of symptoms ; - or/and onset of fever > 38°C

Detailed description

Improvement in functional urinary symptomatology, 2-5 days 28-35 days and 3 months after the start of treatment with FT, Negative ECBU 10 to 12 weeks after end of treatment, negative ECBU (leukocyturia < 10/mm3 OR leukocyturia > 10/mm3 AND bacteriuria < 103/mm3 or bacteriuria with a different pathogen) taken 14 to 21 days after the end of antibiotic treatment, Regression of urinary signs 10 to 12 weeks after the end of treatment, Adverse events reported by the patient and recorded by the investigating physician during antibiotic treatment and in the 14 days following the end of treatment

Interventions

DRUGFOSFOMYCINE ARROW 3 g

Sponsors

CHU De Rouen
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint was defined as the absence of clinical treatment failure up to 14 days after the end of antibiotic treatment. Failure is defined according to SPILF recommendations by : - a change of antibiotic treatment to a reference treatment (see above) for urinary tract infection ; - or/and hospitalization for urinary tract infection ; - or/and acute retention of urine ; - or/and a new consultation for worsening or persistence of symptoms ; - or/and onset of fever > 38°C

Secondary

MeasureTime frame
Improvement in functional urinary symptomatology, 2-5 days 28-35 days and 3 months after the start of treatment with FT, Negative ECBU 10 to 12 weeks after end of treatment, negative ECBU (leukocyturia < 10/mm3 OR leukocyturia > 10/mm3 AND bacteriuria < 103/mm3 or bacteriuria with a different pathogen) taken 14 to 21 days after the end of antibiotic treatment, Regression of urinary signs 10 to 12 weeks after the end of treatment, Adverse events reported by the patient and recorded by the investigating physician during antibiotic treatment and in the 14 days following the end of treatment

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026