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| Name | Class |
|---|---|
| INPADS GmbH | UNKNOWN |
| Dr. Oestreich + Partner GmbH | UNKNOWN |
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The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinical success as defined as clinical cure or clinical improvement | Definition of clinical cure (both criteria must be fulfilled):
Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase). | Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological cure | Definition of microbiological cure:
Time Frame: Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients of the participating study sites (clinics specialised and experienced in the management and treatment of patients suffering from (a part of) the included diseases as mentioned in the respective inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the exclusion criteria, are eligible for participation in the FORTRESS study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Borrmann, Dr. | Contact | Clinical.Trials@infectopharm.com | ||
| Katja Eifert | Contact | Clinical.Trials@infectopharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Klaus-Friedrich Bodmann, Dr. | Klinik Nordoberpfalz AG, Klinikum Weiden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Hall - Tirol Kliniken | Recruiting | Hall in Tirol | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42286374 | Derived | Jarczak D, Kluge S, Kieninger M, Hagel S, Pletz MW, Zoller M, Spies C, Kintrup S, Antonitsch L, Zundel J, Del Bono V, Galfo V, Falcone M, Iasonidou C, Sarmati L, Campogiani L, Bal AM, Dimopoulos G, Vossen MG, Mastroianni CM, Bodmann KF, Herbst C, Mayer C; FORTRESS Study Group. Real-World Data on the Use of Intravenous Fosfomycin for the Treatment of Central Nervous System Infections: a Subgroup Analysis from the FORTRESS Study. Infect Dis Ther. 2026 Jun 13. doi: 10.1007/s40121-026-01383-8. Online ahead of print. | |
| 40106180 |
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| Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment) |
| Microbiological cure | Definition of microbiological cure:
Time Frame: Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase). | Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment) |
| Microbiological cure | Definition of microbiological cure:
Time Frame: Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient. | Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment) |
| Microbiological cure | Definition of microbiological cure:
Time Frame: Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse. | Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") |
| Clinical success as defined as clinical cure or clinical improvement | Definition of clinical cure (both criteria must be fulfilled):
Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment. | Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment) |
| Clinical success as defined as clinical cure or clinical improvement | Definition of clinical cure (both criteria must be fulfilled):
Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient. | Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment) |
| Clinical success as defined as clinical cure or clinical improvement | Definition of clinical cure (both criteria must be fulfilled):
Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse. | Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") |
| Clinical cure | Definition of clinical cure (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase). | Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment) |
| Clinical cure | Definition of clinical cure (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient. | Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment) |
| Clinical cure | Definition of clinical cure (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse. | Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") |
| Clinical improvement | Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment. | Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment) |
| Clinical improvement | Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase). | Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment) |
| Clinical improvement | Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Time point "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient. | Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment) |
| Clinical improvement | Definition of clinical improvement (both criteria must be fulfilled):
Definition of microbiological cure:
Time Frame: Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse. | Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") |
| Sodium serum levels | On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment) |
| Potassium serum levels | On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment) |
| Adverse events | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) |
| Non-serious adverse events | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) |
| Serious adverse events | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) |
| Cases of death | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) |
| Adverse drug reactions (ADRs) | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) |
| Serious adverse drug reactions (SADRs) | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) |
| Dropouts due to treatment failure or due to adverse events | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) |
| A.ö. Bezirkskrankenhaus | Recruiting | Reutte | Austria |
|
| AKH Wien, Universitätsklinik für Innere Medizin 1 | Recruiting | Vienna | Austria |
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| Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie | Recruiting | Wels | Austria |
|
| Universitätsmedizin Charité | Completed | Berlin | 10177 | Germany |
| Vivantes Kliniken Neukölln | Recruiting | Berlin | 12351 | Germany |
|
| Städtisches Klinikum Braunschweig | Recruiting | Braunschweig | 38126 | Germany |
|
| Universitäts Düsseldorf; Klinik für Anästhesiologie | Completed | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Frankfurt | Recruiting | Frankfurt | Germany |
|
| Universität Hamburg-Eppendorf | Recruiting | Hamburg | 20251 | Germany |
|
| Universitätsklinikum Jena; Zentrum für Infektionsmedizin | Recruiting | Jena | 07740 | Germany |
|
| Universitätsklinikum Schleswig-Holstein | Recruiting | Kiel | Germany |
|
| Universitätsklinik Schleswig-Holstein | Recruiting | Lübeck | 23538 | Germany |
|
| LMU München | Recruiting | München | 81377 | Germany |
|
| Universitätsklinikum Münster | Recruiting | Münster | 40149 | Germany |
|
| Klinikum Oldenburg | Recruiting | Oldenburg in Holstein | Germany |
|
| Universitätsklinik Regensburg; Klinik für Anästhesiologie | Recruiting | Regensburg | 93053 | Germany |
|
| Kliniken Nordoberpfalz | Completed | Weiden | 92637 | Germany |
| General Oncology Hospital of Kifissia "Agioi Anargiroi" | Recruiting | Kifissia | Athens | Greece |
|
| General Hospital of Athens "Evangelismos" | Recruiting | Athens | Greece |
|
| Sotiria Thoracic Diseases Hospital of Athens | Recruiting | Athens | Greece |
|
| University General Hospital "ATTIKON" | Recruiting | Athens | Greece |
|
| General Hospital of Attica "KAT" | Recruiting | Kifissia | Greece |
|
| General Hospital of Lamia | Recruiting | Lamia | Greece |
|
| RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases | Recruiting | Pátrai | Greece |
|
| "AHEPA" University General Hospital of Thessaloniki | Recruiting | Thessaloniki | Greece |
|
| General Hospital of Thessaloniki "G. GENIMMATAS" | Recruiting | Thessaloniki | Greece |
|
| General Hospital of Thessaloniki "Hippokration" | Recruiting | Thessaloniki | Greece |
|
| General Hospital of Thessaloniki "G. Papanikolaou" | Recruiting | Thessaloniki | Greece |
|
| Clinical Malattie Infettive | Recruiting | Bari | 70124 | Italy |
|
| Azienda Ospedaliera S.Croce e Carle | Recruiting | Cuneo | Italy |
|
| Ospedal Policlinico San Martino | Recruiting | Genova | Italy |
|
| Ospedale L. Sacco | Active, not recruiting | Milan | Italy |
| Istituto Mediterraneo per i Trapianti Ismett IRCCS | Recruiting | Palermo | Italy |
|
| Policlinico Paolo Giaccone | Recruiting | Palermo | Italy |
|
| Policlinico Umberto I, Malattie Infettive | Recruiting | Rome | 00161 | Italy |
|
| Lazzaro Spallanzani | Recruiting | Rome | Italy |
|
| Polocinico Tor Vergata | Recruiting | Rome | Italy |
|
| AOU Città della Salute e Scienza-Presidio Molinette | Recruiting | Torino | Italy |
|
| Ospedale S.M.della Misericordia | Recruiting | Udine | Italy |
|
| ASST-Sette Lagh Viale Borre | Recruiting | Varese | Italy |
|
| Royal Bolton Hospital | Active, not recruiting | Bolton | BL4 0JR | United Kingdom |
| Hull & East Yorkshire Hospitals NHS Trust | Recruiting | Cottingham | HU16 5JQ | United Kingdom |
|
| Ninewells Hospital | Recruiting | Dundee | DD1 9SY | United Kingdom |
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| Queen Elisabeth University Hospital | Recruiting | Glasgow | United Kingdom |
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| University of Glasgow/Royal Infirmary | Recruiting | Glasgow | United Kingdom |
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| University Hospital Crosshouse | Recruiting | Kilmarnock | KA2OBB | United Kingdom |
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| Chelsea & Westminster Hospial | Recruiting | London | United Kingdom |
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| Queen Elisabeth Hospital | Recruiting | London | United Kingdom |
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| Univresity College Londen (UCL) Hospital | Recruiting | London | United Kingdom |
|
| Derived |
| Bodmann KF, Hagel S, Oliva A, Kluge S, Mularoni A, Galfo V, Falcone M, Pletz MW, Lindau S, Kading N, Kielstein JT, Zoller M, Tascini C, Kintrup S, Schadler D, Spies C, De Rosa FG, Radnoti S, Bandera A, Luzzati R, Allen S, Sarmati L, Cascio A, Kapravelos N, Subudhi CPK, Dimopoulos G, Vossen MG, Bal AM, Venditti M, Mastroianni CM, Borrmann T, Mayer C. Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study. Infect Dis Ther. 2025 Apr;14(4):765-791. doi: 10.1007/s40121-025-01125-2. Epub 2025 Mar 19. |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001850 | Bone Diseases, Infectious |
| D010019 | Osteomyelitis |
| D020806 | Central Nervous System Bacterial Infections |
| D016920 | Meningitis, Bacterial |
| D004660 | Encephalitis |
| D001922 | Brain Abscess |
| D014552 | Urinary Tract Infections |
| D012141 | Respiratory Tract Infections |
| D018410 | Pneumonia, Bacterial |
| D017192 | Skin Diseases, Bacterial |
| D018461 | Soft Tissue Infections |
| D059413 | Intraabdominal Infections |
| D018805 | Sepsis |
| D016470 | Bacteremia |
| D004697 | Endocarditis, Bacterial |
| D016905 | Gram-Negative Bacterial Infections |
| D016908 | Gram-Positive Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D001927 | Brain Diseases |
| D000038 | Abscess |
| D013492 | Suppuration |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012140 | Respiratory Tract Diseases |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053821 | Cardiovascular Infections |
| D002318 | Cardiovascular Diseases |
| D004696 | Endocarditis |
| D006331 | Heart Diseases |
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