Fosfomycin I.v. for Treatment of Severely Infected Patients
FORTRESS
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.
1 other identifier
observational
1,000
5 countries
50
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
October 1, 2024
September 1, 2024
14 years
November 24, 2016
September 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with clinical success as defined as clinical cure or clinical improvement
Definition of clinical cure (both criteria must be fulfilled): * Resolution of signs and symptoms and * microbiological cure or no additional antibiotic therapy for the targeted infection necessary. Definition of clinical improvement (both criteria must be fulfilled): * Partial resolution of signs and symptoms and * microbiological cure or no additional antibiotic therapy for the targeted infection necessary. Definition of microbiological cure: * Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or * in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered. 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)
Secondary Outcomes (23)
Microbiological cure
Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
Microbiological cure
Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Microbiological cure
Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
Microbiological cure
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
Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
- +18 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- Male or female patients aged ≥ 18 years
- Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.
- 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 infection, each as far as covered by the respective nationally relevant SmPC
- Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)
You may not qualify if:
- Previous documentation of the patient in the present study
- Patients participating in an interventional clinical trial
- Patients with known hypersensitivity to fosfomycin or any of the excipients
- Terminally ill patients
- Patients with "do not resuscitate order"
- Palliative treatment approach
- Failure of \> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney
- Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)
- Fosfomycin treatment as 4th line treatment or at later stage
- Patients with involvement of fungi or mycobacteria in the targeted infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Infectopharm Arzneimittel GmbHlead
- INPADS GmbHcollaborator
- Dr. Oestreich + Partner GmbHcollaborator
Study Sites (50)
Landeskrankenhaus Hall - Tirol Kliniken
Hall in Tirol, Austria
A.ö. Bezirkskrankenhaus
Reutte, Austria
AKH Wien, Universitätsklinik für Innere Medizin 1
Vienna, Austria
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
Wels, Austria
Universitätsmedizin Charité
Berlin, 10177, Germany
Vivantes Kliniken Neukölln
Berlin, 12351, Germany
Städtisches Klinikum Braunschweig
Braunschweig, 38126, Germany
Universitäts Düsseldorf; Klinik für Anästhesiologie
Düsseldorf, 40225, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Universität Hamburg-Eppendorf
Hamburg, 20251, Germany
Universitätsklinikum Jena; Zentrum für Infektionsmedizin
Jena, 07740, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universitätsklinik Schleswig-Holstein
Lübeck, 23538, Germany
LMU München
München, 81377, Germany
Universitätsklinikum Münster
Münster, 40149, Germany
Klinikum Oldenburg
Oldenburg in Holstein, Germany
Universitätsklinik Regensburg; Klinik für Anästhesiologie
Regensburg, 93053, Germany
Kliniken Nordoberpfalz
Weiden, 92637, Germany
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Kifissia, Athens, Greece
General Hospital of Athens "Evangelismos"
Athens, Greece
Sotiria Thoracic Diseases Hospital of Athens
Athens, Greece
University General Hospital "ATTIKON"
Athens, Greece
General Hospital of Attica "KAT"
Kifissia, Greece
General Hospital of Lamia
Lamia, Greece
RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases
Pátrai, Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, Greece
General Hospital of Thessaloniki "G. GENIMMATAS"
Thessaloniki, Greece
General Hospital of Thessaloniki "Hippokration"
Thessaloniki, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, Greece
Clinical Malattie Infettive
Bari, 70124, Italy
Azienda Ospedaliera S.Croce e Carle
Cuneo, Italy
Ospedal Policlinico San Martino
Genova, Italy
Ospedale L. Sacco
Milan, Italy
Istituto Mediterraneo per i Trapianti Ismett IRCCS
Palermo, Italy
Policlinico Paolo Giaccone
Palermo, Italy
Policlinico Umberto I, Malattie Infettive
Rome, 00161, Italy
Lazzaro Spallanzani
Rome, Italy
Polocinico Tor Vergata
Rome, Italy
AOU Città della Salute e Scienza-Presidio Molinette
Torino, Italy
Ospedale S.M.della Misericordia
Udine, Italy
ASST-Sette Lagh Viale Borre
Varese, Italy
Royal Bolton Hospital
Bolton, BL4 0JR, United Kingdom
Hull & East Yorkshire Hospitals NHS Trust
Cottingham, HU16 5JQ, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Queen Elisabeth University Hospital
Glasgow, United Kingdom
University of Glasgow/Royal Infirmary
Glasgow, United Kingdom
University Hospital Crosshouse
Kilmarnock, KA2OBB, United Kingdom
Chelsea & Westminster Hospial
London, United Kingdom
Queen Elisabeth Hospital
London, United Kingdom
Univresity College Londen (UCL) Hospital
London, United Kingdom
Related Publications (1)
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.
PMID: 40106180DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Klaus-Friedrich Bodmann, Dr.
Klinik Nordoberpfalz AG, Klinikum Weiden
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2016
First Posted
December 2, 2016
Study Start
December 1, 2016
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share