Clinical trial NCT06814899: Use of Fosfomycin in the Treatment of Bacterial Infections
Official title: Use of Fosfomycin in the Treatment of Bacterial Infections: "real-life" Study At the ASST of Lecco
Study type: OBSERVATIONAL
Overall 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
Lead sponsor: Azienda Ospedaliera di Lecco
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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


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).

Primary outcomes:
measure: Evaluation of the clinical outcome of all patients treated with IV fosfomycin
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Stefania Piconi
Study officials:
References: