Scholarlink

Introduction <p>Intravenous fosfomycin (FOS) is a broad-spectrum antibiotic primarily used in combination therapy to treat severe infections caused by both Gram-positive (GP) and Gram-negative (GN) pathogens, including multi-drug resistant (MDR) bacteria. The aim of this study, the largest to date, was to evaluate the effectiveness, safety, usage patterns, and patient characteristics of FOS in a real-world setting.</p> Methods <p>Interim analysis of an ongoing, prospective, non-interventional, multicentre study in five European countries, involving centres in Germany, Italy, the United Kingdom, Greece, and Austria.</p> Results <p>A total of 716 patients were enrolled between January 2017 and November 2023 (mean age: 62.8 years, APACHE II: 18.3, SOFA: 6.7). Main indications for FOS were bacteraemia/sepsis (23.6%), complicated urinary tract infections (18.0%), and bone and joint infections (17.4%). Other indications included hospital-acquired/ventilator-associated pneumonia (11.0%), complicated skin and soft tissue infections (9.1%), bacterial meningitis/central nervous system (CNS) infections (7.8%), and infective endocarditis (6.4%). Most common pathogens identified were <i>Staphylococcus&#xa0;aureus</i> (31.4%, including methicillin-resistant <i>S.&#xa0;aureus</i>), <i>Klebsiella</i>&#xa0;spp. (including <i>K.&#xa0;pneumoniae</i>) (17.2%), <i>Escherichia&#xa0;coli</i> (14.2%), coagulase-negative staphylococci (12.9%), other Enterobacterales (10.9%), and <i>Pseudomonas&#xa0;aeruginosa</i> (8.4%). In 34.6% of patients, an MDR pathogen was involved. Carbapenem resistance (CR) was high in <i>Klebsiella</i>&#xa0;spp. infections (59/123, 48.0%). In most patients, FOS was used in combination therapy (90.2%). The median dose was 15 g/day. Overall, clinical success and clinical response were favourable with 75.3% and 83.4% at the end of FOS treatment. Clinical success rates in infections caused by MDR or CR pathogens were 78.0% and 81.8%, respectively. Microbiological cure was achieved in 82.4% of all patients. Electrolyte imbalances were the most frequently observed adverse drug reactions, while gastrointestinal disorders were rare.</p> Conclusion <p>The results from this study suggest that FOS is a safe and effective option as combination partner in the treatment of patients with severe infections caused by both GP and GN pathogens, including deep-seated infections and/or involvement of MDR bacteria.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT02979951.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年3月19日

查看全文
  • Klaus-Friedrich Bodmann,
  • Stefan Hagel,
  • Alessandra Oliva,
  • Stefan Kluge,
  • Alessandra Mularoni,
  • Valentina Galfo,
  • Marco Falcone,
  • Mathias W. Pletz,
  • Simone Lindau,
  • Nadja Käding,
  • Jan T. Kielstein,
  • Michael Zoller,
  • Carlo Tascini,
  • Sebastian Kintrup,
  • Dirk Schädler,
  • Claudia Spies,
  • Francesco G. De Rosa,
  • Szilvia Radnoti,
  • Alessandra Bandera,
  • Roberto Luzzati,
  • Sam Allen,
  • Loredana Sarmati,
  • Antonio Cascio,
  • Nikolaos Kapravelos,
  • Chinari P. K. Subudhi,
  • George Dimopoulos,
  • Matthias G. Vossen,
  • Abhijit M. Bal,
  • Mario Venditti,
  • Claudio M. Mastroianni,
  • Thomas Borrmann,
  • Christian Mayer

摘要

Introduction

Intravenous fosfomycin (FOS) is a broad-spectrum antibiotic primarily used in combination therapy to treat severe infections caused by both Gram-positive (GP) and Gram-negative (GN) pathogens, including multi-drug resistant (MDR) bacteria. The aim of this study, the largest to date, was to evaluate the effectiveness, safety, usage patterns, and patient characteristics of FOS in a real-world setting.

Methods

Interim analysis of an ongoing, prospective, non-interventional, multicentre study in five European countries, involving centres in Germany, Italy, the United Kingdom, Greece, and Austria.

Results

A total of 716 patients were enrolled between January 2017 and November 2023 (mean age: 62.8 years, APACHE II: 18.3, SOFA: 6.7). Main indications for FOS were bacteraemia/sepsis (23.6%), complicated urinary tract infections (18.0%), and bone and joint infections (17.4%). Other indications included hospital-acquired/ventilator-associated pneumonia (11.0%), complicated skin and soft tissue infections (9.1%), bacterial meningitis/central nervous system (CNS) infections (7.8%), and infective endocarditis (6.4%). Most common pathogens identified were Staphylococcus aureus (31.4%, including methicillin-resistant S. aureus), Klebsiella spp. (including K. pneumoniae) (17.2%), Escherichia coli (14.2%), coagulase-negative staphylococci (12.9%), other Enterobacterales (10.9%), and Pseudomonas aeruginosa (8.4%). In 34.6% of patients, an MDR pathogen was involved. Carbapenem resistance (CR) was high in Klebsiella spp. infections (59/123, 48.0%). In most patients, FOS was used in combination therapy (90.2%). The median dose was 15 g/day. Overall, clinical success and clinical response were favourable with 75.3% and 83.4% at the end of FOS treatment. Clinical success rates in infections caused by MDR or CR pathogens were 78.0% and 81.8%, respectively. Microbiological cure was achieved in 82.4% of all patients. Electrolyte imbalances were the most frequently observed adverse drug reactions, while gastrointestinal disorders were rare.

Conclusion

The results from this study suggest that FOS is a safe and effective option as combination partner in the treatment of patients with severe infections caused by both GP and GN pathogens, including deep-seated infections and/or involvement of MDR bacteria.

Trial Registration

ClinicalTrials.gov identifier, NCT02979951.