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
{"title":"现实世界中静脉注射磷霉素的使用、有效性和安全性：FORTRESS研究。","authors":"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","doi":"10.1007/s40121-025-01125-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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><p><strong>Methods: </strong>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><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT02979951.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":""},"PeriodicalIF":4.7000,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study.\",\"authors\":\"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\",\"doi\":\"10.1007/s40121-025-01125-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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><p><strong>Methods: </strong>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><p><strong>Results: </strong>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. 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Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study.
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.
期刊介绍：
Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.
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