Use of Fosfomycin in the Treatment of Bacterial Infections (FOSFOREAL LIFE)

Use of Fosfomycin in the Treatment of Bacterial Infections: "real-life" Study At the ASST of Lecco

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

Study Overview

• Status: Recruiting
• Conditions: Analyze the Medical Records of Patients Admitted At ASST Lecco from 01/04/2020 to 31/12/2023 Treated with Fosfomycin IV
• Intervention / Treatment: Drug: Fosfomycin

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Stefania Piconi, MD; Phone Number: +390341489890; Email: s.piconi@asst-lecco.it
• Study Contact Backup: Name: Silvia Pontiggia, MS; Phone Number: +390341253678; Email: s.pontiggia@asst-lecco.it

Study Locations

• Italy
  • Lecco, Italy, 23900
    • Recruiting
    • Stefania Piconi
    • Contact: Stefania Piconi, MD; Phone Number: +390341489890; Email: s.piconi@asst-lecco.it
    • Contact: Silvia Pontiggia, MS; Phone Number: +390341253678; Email: s.pontiggia@asst-lecco.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at A. Manzoni Lecco between April 2020 and December 2023 and treated with IV fosfomycin as monotherapy or in combination with another antibiorics

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the clinical outcome of all patients treated with IV fosfomycin	Evaluation of the clinical outcome of all patients treated with IV fosfomycin intended as negative culture tests and resolution of clinical symptoms.	3 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Lecco

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Anti-Bacterial Agents; Anti-Infective Agents; Fosfomycin
• Other Study ID Numbers: FOSFOREAL LIFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No