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NCT Number: NCT06814899

Use of Fosfomycin in the Treatment of Bacterial Infections

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of the clinical outcome of all patients treated with IV fosfomycin

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Pontiggia, MS

CONTACT

[email protected]

+390341253678

Stefania Piconi, MD

CONTACT

[email protected]

+390341489890

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Lecco

Other

Registry information

Official study title

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

Acronym: FOSFOREAL LIFE

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.