Evidence map›Paper›PMID 40106180›Full record

ArticleInfectious diseases and therapy2025

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

Klaus-Friedrich Bodmann, Stefan Hagel, Alessandra Oliva, Stefan Kluge, Alessandra Mularoni, Valentina Galfo, Marco Falcone, Mathias W Pletz, Simone Lindau, Nadja Käding and 22 more

Registry-linked trialAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02979951 (An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02979951 recruitingnot on this map

An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.

TypeobservationalSponsorInfectopharm Arzneimittel GmbHRan2016 to 2030Enrolled1,000ConditionsBacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Treatment Options for Metallo-Beta-Lactamase-ProducingInternational journal of molecular sciences · 2026
    Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Klaus-Friedrich Bodmann *Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden, Germany.
Stefan Hagel *Institute for Infectious Diseases and Infection Control, Jena University Hospital, Friedrich-Schiller-University, Jena, Germany. stefan.hagel@uni-jena.de.ORCID http://orcid.org/0000-0003-2999-6131
Alessandra OlivaDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Stefan KlugeDepartment of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Alessandra MularoniIRCCS-ISMETT, Palermo, Italy.
Valentina GalfoDepartment of Clinical and Experimental Medicine, Azienda Ospedaliero Universitaria Pisana, University of Pisa, Pisa, Italy.
Marco FalconeDepartment of Clinical and Experimental Medicine, Azienda Ospedaliero Universitaria Pisana, University of Pisa, Pisa, Italy.
Mathias W PletzInstitute for Infectious Diseases and Infection Control, Jena University Hospital, Friedrich-Schiller-University, Jena, Germany.
Simone LindauDepartment of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Frankfurt, Goethe-University Frankfurt, Frankfurt, Germany.
Nadja KädingDepartment of Infectious Diseases and Microbiology, University of Luebeck, Luebeck, Germany.
Jan T KielsteinMedical Clinic V Nephrology, Rheumatology, Blood Purification - Academic Teaching Hospital Braunschweig, Brunswick, Germany.
Michael ZollerDepartment of Anaesthesiology, LMU University Hospital, LMU Munich, Munich, Germany.
Carlo TasciniDepartment of Medicine (DMED), Infectious Diseases Clinic, University of Udine, Udine, Italy.
Sebastian KintrupDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany.
Dirk SchädlerDepartment for Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Claudia SpiesDepartment of Anaesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany.
Francesco G De RosaDepartment of Medical Sciences, Infectious Diseases, University of Turin, Turin, Italy.
Szilvia RadnotiKliniken Nordoberpfalz AG, Klinikum Weiden, Weiden, Germany.
Alessandra BanderaInfectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Milan, Italy.
Roberto LuzzatiClinical Department of Medical, Surgical and Health Sciences, Trieste University, Trieste, Italy.
Sam AllenDepartment of Microbiology, University Hospital Crosshouse, Kilmarnock, UK.
Loredana SarmatiDepartment of Infectious Diseases, University Hospital Tor Vergata, Rome, Italy.
Antonio CascioInfectious and Tropical Diseases Unit, AOU Policlinico "P. Giaccone", University of Palermo, Palermo, Italy.
Nikolaos KapravelosIntensive Care Unit, G Papanikolaou General Hospital, Exohi, Thessaloniki, Greece.
Chinari P K SubudhiRoyal Bolton Hospital, Bolton, UK.
George DimopoulosThird Department of Critical Care Medicine, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Matthias G VossenDivision of Infectious Diseases and Tropical Medicine, Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria.
Abhijit M BalDepartment of Microbiology, Queen Elizabeth University Hospital, Glasgow, UK.
Mario VendittiDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Claudio M MastroianniDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Thomas Borrmann *InfectoPharm Arzneimittel und Consilium GmbH, Heppenheim, Germany.
Christian Mayer *InfectoPharm Arzneimittel und Consilium GmbH, Heppenheim, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIntravenous 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.

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

resultsA 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.

conclusionThe 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 registrationClinicalTrials.gov identifier, NCT02979951.

Indexed as

BacteraemiaCarbapenem-resistant EnterobacteralesFosfomycinInfective endocarditisKlebsiella pneumoniaeMDRObservational studyPseudomonas aeruginosaSepsisStaphylococcus aureus

Identifiers

PMID40106180
PMCPMC11993532

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.