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Recruiting Observational

Use of Fosfomycin in the Treatment of Bacterial Infections

NCT06814899 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliera di Lecco
Phase
Observational
Started
2020-04-01
Last updated
2025-02-07

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Fosfomycin →

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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Evaluation of the clinical outcome of all patients treated with IV fosfomycin — 3 months
    Evaluation of the clinical outcome of all patients treated with IV fosfomycin intended as negative culture tests and resolution of clinical symptoms.

Trial sites (1)

FacilityCityRegionStatus
Stefania Piconi Lecco Lecco Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06814899 on ClinicalTrials.gov ↗ ← All trials in Italy