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Intravenous Fosfomycin in hospitalized patients with complicated urinary tract infections due to Third-generation cephalosporinresistant Enterobacterales

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516591-15-00
Enrollment
548
Registered
2024-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-12

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

Conditions

urinary tract infections

Brief summary

Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)

Detailed description

Clinical cure rates in the 2 treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at TOC;clinical evaluation after 48 h from first drug administration;microbiological eradication rates in m-MITT and ME populations at TOC;Mortality for any reason until day 30;Hospital readmissions or extended hospitalization; Number of hospital re-admissions until day 90;Relapse or reinfections;Clostridioides difficile associated diarrhea;AE related to fosfomycin treatment

Interventions

DRUGFOSFOMYCIN
DRUGERTAPENEM

Sponsors

Azienda Ospedaliero Universitaria Di Modena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)

Secondary

MeasureTime frame
Clinical cure rates in the 2 treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at TOC;clinical evaluation after 48 h from first drug administration;microbiological eradication rates in m-MITT and ME populations at TOC;Mortality for any reason until day 30;Hospital readmissions or extended hospitalization; Number of hospital re-admissions until day 90;Relapse or reinfections;Clostridioides difficile associated diarrhea;AE related to fosfomycin treatment

Countries

Italy

Outcome results

None listed

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