Use of Fosfomycin in the Treatment of Bacterial Infections

NCT06814899 | Recruiting

• 1 other identifier: FOSFOREAL LIFE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Fosfomycin DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera di Lecco: lead

Study Sites (1)

Stefania Piconi

Lecco, Lecco, 23900, Italy

RECRUITING

MeSH Terms

Interventions

Fosfomycin

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Central Study Contacts

Stefania Piconi, MD

CONTACT

+390341489890; s.piconi@asst-lecco.it

Silvia Pontiggia, MS

CONTACT

+390341253678; s.pontiggia@asst-lecco.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Infectious Diseases Unit

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: February 7, 2025
• Study Start: April 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)