Real-World Use, Effectiveness, and Safety of Intravenous Fosfomycin: The FORTRESS Study.
Klaus-Friedrich Bodmann, Stefan Hagel, Alessandra Oliva...
https://pubmed.ncbi.nlm.nih.gov/40106180Actively Recruiting
Age: 18Years +
All Genders
ID02979951
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.
Led by Infectopharm Arzneimittel GmbH · Updated on 2024-10-01
1000
Participants Needed
50
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Infectopharm Arzneimittel GmbH
Lead Sponsor
I
INPADS GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of intravenously administered fosfomycin in treating severely infected patients across Europe. This prospective, multicenter, non-interventional study focuses on infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis or central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections covered by national guidelines. Patients receive fosfomycin intravenously according to the respective national Summary of Product Characteristics (SmPC). The study is observational and does not involve randomization or placebo. It includes monitoring during treatment and follow-up periods, with evaluations up to six months for treatment outcomes and up to one year for osteomyelitis follow-up. The study documents clinical and microbiological cure rates, clinical improvements, and sodium and potassium serum levels during hospital stays. Participants are assessed for clinical success at multiple points, including initial response (within 7 days), end of treatment (up to 6 months), test of cure, and follow-up (up to one year for osteomyelitis). Safety monitoring includes daily recording of adverse events, serious adverse events, adverse drug reactions, and deaths during treatment and follow-up. The study tracks dropouts due to treatment failure or adverse events. Overall, participation duration varies depending on treatment and follow-up schedules.
CONDITIONS
Brief Title
Fosfomycin I.v. for Treatment of Severely Infected Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Treatment with fosfomycin according to the national Summary of Product Characteristics (SmPC)
- Diagnosed with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis or central nervous system infection, bacteraemia or sepsis, skin and soft tissue infection, endocarditis, or other infections covered by national SmPC
- Provided written informed consent or consent from a legal representative if unable to consent
You will not qualify if you...
- Previously documented in this study
- Currently participating in an interventional clinical trial
- Known hypersensitivity to fosfomycin or its excipients
- Terminally ill patients
- Patients with do not resuscitate orders
- Receiving palliative treatment
- Failure of more than three organ systems including respiratory, nervous, cardiovascular, liver, coagulation, or kidney
- Diagnosed with advanced HIV/AIDS
- Fosfomycin used as fourth-line or later treatment
- Infection involving fungi or mycobacteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months from start of fosfomycin treatment
Participants receive fosfomycin treatment as prescribed by their healthcare provider according to national guidelines.
Daily assessments during hospital stay
Follow-up
Duration - Up to 1 year from start of fosfomycin treatment
Participants are monitored for safety and clinical outcomes after treatment ends.
Daily safety monitoring during follow-up period
Trial Site Locations
Total: 50 locations
1
Landeskrankenhaus Hall - Tirol Kliniken
Hall in Tirol, Austria
Actively Recruiting
2
A.ö. Bezirkskrankenhaus
Reutte, Austria
Actively Recruiting
3
AKH Wien, Universitätsklinik für Innere Medizin 1
Vienna, Austria
Actively Recruiting
4
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
Wels, Austria
Actively Recruiting
5
Universitätsmedizin Charité
Berlin, Germany, 10177
Completed
6
Vivantes Kliniken Neukölln
Berlin, Germany, 12351
Actively Recruiting
7
Städtisches Klinikum Braunschweig
Braunschweig, Germany, 38126
Actively Recruiting
8
Universitäts Düsseldorf; Klinik für Anästhesiologie
Düsseldorf, Germany, 40225
Completed
9
Universitätsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
10
Universität Hamburg-Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
11
Universitätsklinikum Jena; Zentrum für Infektionsmedizin
Jena, Germany, 07740
Actively Recruiting
12
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Actively Recruiting
13
Universitätsklinik Schleswig-Holstein
Lübeck, Germany, 23538
Actively Recruiting
14
LMU München
München, Germany, 81377
Actively Recruiting
15
Universitätsklinikum Münster
Münster, Germany, 40149
Actively Recruiting
16
Klinikum Oldenburg
Oldenburg in Holstein, Germany
Actively Recruiting
17
Universitätsklinik Regensburg; Klinik für Anästhesiologie
Regensburg, Germany, 93053
Actively Recruiting
18
Kliniken Nordoberpfalz
Weiden, Germany, 92637
Completed
19
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Kifissia, Athens, Greece
Actively Recruiting
20
General Hospital of Athens "Evangelismos"
Athens, Greece
Actively Recruiting
21
Sotiria Thoracic Diseases Hospital of Athens
Athens, Greece
Actively Recruiting
22
University General Hospital "ATTIKON"
Athens, Greece
Actively Recruiting
23
General Hospital of Attica "KAT"
Kifissia, Greece
Actively Recruiting
24
General Hospital of Lamia
Lamia, Greece
Actively Recruiting
25
RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases
Pátrai, Greece
Actively Recruiting
26
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
27
General Hospital of Thessaloniki "G. GENIMMATAS"
Thessaloniki, Greece
Actively Recruiting
28
General Hospital of Thessaloniki "Hippokration"
Thessaloniki, Greece
Actively Recruiting
29
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, Greece
Actively Recruiting
30
Clinical Malattie Infettive
Bari, Italy, 70124
Actively Recruiting
31
Azienda Ospedaliera S.Croce e Carle
Cuneo, Italy
Actively Recruiting
32
Ospedal Policlinico San Martino
Genova, Italy
Actively Recruiting
33
Ospedale L. Sacco
Milan, Italy
Active, Not Recruiting
34
Istituto Mediterraneo per i Trapianti Ismett IRCCS
Palermo, Italy
Actively Recruiting
35
Policlinico Paolo Giaccone
Palermo, Italy
Actively Recruiting
36
Policlinico Umberto I, Malattie Infettive
Rome, Italy, 00161
Actively Recruiting
37
Lazzaro Spallanzani
Rome, Italy
Actively Recruiting
38
Polocinico Tor Vergata
Rome, Italy
Actively Recruiting
39
AOU Città della Salute e Scienza-Presidio Molinette
Torino, Italy
Actively Recruiting
40
Ospedale S.M.della Misericordia
Udine, Italy
Actively Recruiting
41
ASST-Sette Lagh Viale Borre
Varese, Italy
Actively Recruiting
42
Royal Bolton Hospital
Bolton, United Kingdom, BL4 0JR
Active, Not Recruiting
43
Hull & East Yorkshire Hospitals NHS Trust
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
44
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
45
Queen Elisabeth University Hospital
Glasgow, United Kingdom
Actively Recruiting
46
University of Glasgow/Royal Infirmary
Glasgow, United Kingdom
Actively Recruiting
47
University Hospital Crosshouse
Kilmarnock, United Kingdom, KA2OBB
Actively Recruiting
48
Chelsea & Westminster Hospial
London, United Kingdom
Actively Recruiting
49
Queen Elisabeth Hospital
London, United Kingdom
Actively Recruiting
50
Univresity College Londen (UCL) Hospital
London, United Kingdom
Actively Recruiting
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Research Team
T
Thomas Borrmann, Dr.
K
Katja Eifert
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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