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Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study

Klaus-Friedrich Bodmann1, Stefan Hagel2, Alessandra Oliva3

  • 1Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden, Germany.

Infectious Diseases and Therapy
|March 19, 2025
PubMed
Abstract

Insights

Intravenous fosfomycin (FOS) effectively treats severe Gram-positive and Gram-negative infections, including those caused by multi-drug resistant bacteria. This large real-world study confirms its safety and efficacy as a combination therapy partner.

Area of Science:

  • Infectious Diseases
  • Pharmacology
  • Clinical Microbiology

Background:

  • Intravenous fosfomycin (FOS) is a broad-spectrum antibiotic used for severe infections.
  • It is often employed in combination therapy against Gram-positive (GP) and Gram-negative (GN) pathogens, including multi-drug resistant (MDR) bacteria.

Purpose of the Study:

  • To evaluate the real-world effectiveness, safety, usage patterns, and patient characteristics of intravenous FOS.
  • This study represents the largest evaluation of FOS to date.

Main Methods:

  • Interim analysis of a prospective, non-interventional, multicentre study.
  • Data collected from 716 patients across five European countries (Germany, Italy, UK, Greece, Austria) between January 2017 and November 2023.

Main Results:

  • Common indications included bacteraemia/sepsis, complicated urinary tract infections, and bone/joint infections.
  • Prevalence of MDR pathogens was 34.6%, with high carbapenem resistance (48.0%) in Klebsiella spp. infections.
  • FOS demonstrated favorable clinical success (75.3%) and microbiological cure (82.4%), including in MDR/CR infections (78.0%). Electrolyte imbalances were the most common adverse drug reactions.

Conclusions:

  • Intravenous fosfomycin is a safe and effective combination therapy agent for severe GP and GN infections.
  • It is particularly valuable for deep-seated infections and those involving MDR bacteria.
Keywords:
Klebsiella pneumoniaePseudomonas aeruginosaStaphylococcus aureusBacteraemiaCarbapenem-resistant EnterobacteralesFosfomycinInfective endocarditisMDRObservational studySepsis

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