Use of Fosfomycin in the Treatment of Bacterial Infections

NCT ID: NCT06814899

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2025-01-31

Brief Summary

Fosfomycin is an antibiotic discovered since 1969. Disodium fosfomycin, for intravenous use (C3H5Na2O4P) is a bactericidal antibiotic, available in Italy since 2019 (AIFA approval). It works by blocking the enzyme UDP-N-acetylglucosamine enolpyruvil transferase, inhibiting the synthesis of peptidoglycan. It binds poorly to plasma proteins and is distributed very well in various tissues such as: eyes, bones, skin and subcutaneous tissue, muscles, lungs, prostate, bile and inflamed meninges. It also has a strong anti-biofilm activity.

Fosfomycin is active against Gram-positive bacteria (staphylococci, streptococci, enterococci, including MRSA and VRE) and Gram-negative bacteria (Enterobacterales, Haemophilus influenzae, Proteus mirabilis, Pseudomonas aeruginosa, including MDR strains) and against difficult-to-treat bacteria such as Serratia marcescens, Stenotrophomonas maltophilia, Bacteroides spp and intracellular bacteria such as Chlamydia and Mycoplasma. It has no activity against Acinetobacter spp, Peptococcus spp. and Peptostreptococcus spp, Burkholderia cepacia, and Mycobacterium tuberculosis.

IV fosfomycin is approved for the treatment of osteomyelitis, complicated urinary tract infections, pneumonia including hospital-acquired and ventilator-associated pneumonia, complicated skin and soft tissue infections, bacterial meningitis, and complicated bacteremia.

In this retrospective study, the investigators want to analyze the medical records of all patients admitted to the ASST of Lecco from 01/04/2020 to 31/12/2023 treated with fosfomycin IV in order to evaluate different clinical outcomes given the recent introduction at ASST Lecco

Conditions

Analyze the Medical Records of Patients Admitted At ASST Lecco from 01/04/2020 to 31/12/2023 Treated with Fosfomycin IV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Fosfomycin

In this retrospective study, the investigators want to analyze the medical records of all patients admitted to the Lecco ASST from 04/01/2020 to 12/31/2023 treated with IV fosfomycin in order to evaluate different clinical outcomes.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age > 18 years;
• Patients hospitalized at A. Manzoni Lecco between April 2020 and December 2023;
• Patients treated with IV fosfomycin as monotherapy or in combination with other antibiotics for at least 72 hours.

Exclusion Criteria

• Patients who received fosfomycin IV for less than 72h for any cause (death, adverse events, clinical decision).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera di Lecco

OTHER

Sponsor Role: lead

Responsible Party

Stefania Piconi

Director of Infectious Diseases Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stefania Piconi

Lecco, Lecco, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefania Piconi, MD

Role: CONTACT

s.piconi@asst-lecco.it

+390341489890

Silvia Pontiggia, MS

Role: CONTACT

s.pontiggia@asst-lecco.it

+390341253678

Facility Contacts

Stefania Piconi, MD

Role: primary

s.piconi@asst-lecco.it

+390341489890

Silvia Pontiggia, MS

Role: backup

s.pontiggia@asst-lecco.it

+390341253678

Other Identifiers

FOSFOREAL LIFE

Identifier Type: -

Identifier Source: org_study_id