Fosfomycin I.v. for Treatment of Severely Infected Patients
- Conditions
- Central Nervous System Bacterial InfectionsSkin Diseases, BacterialSoft Tissue InfectionsIntraabdominal InfectionsSepsisEndocarditis, BacterialRespiratory Tract InfectionsBone Diseases, InfectiousMeningitis, BacterialBrain Abscess
- Registration Number
- NCT02979951
- Lead Sponsor
- Infectopharm Arzneimittel GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with clinical success as defined as clinical cure or clinical improvement Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment) 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).
- Secondary Outcome Measures
Name Time Method Microbiological cure Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") 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:
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.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) 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) Clinical success as defined as clinical cure or clinical improvement Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") 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:
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.Clinical cure Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") 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 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:
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.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) 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) 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) Clinical improvement Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") 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:
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.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) 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)
Trial Locations
- Locations (50)
General Hospital of Athens "Evangelismos"
🇬🇷Athens, Greece
University General Hospital "ATTIKON"
🇬🇷Athens, Greece
General Hospital of Lamia
🇬🇷Lamia, Greece
"AHEPA" University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "G. GENIMMATAS"
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloníki, Greece
Landeskrankenhaus Hall - Tirol Kliniken
🇦🇹Hall In Tirol, Austria
A.ö. Bezirkskrankenhaus
🇦🇹Reutte, Austria
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
🇦🇹Wels, Austria
AKH Wien, Universitätsklinik für Innere Medizin 1
🇦🇹Wien, Austria
Universitätsmedizin Charité
🇩🇪Berlin, Germany
Vivantes Kliniken Neukölln
🇩🇪Berlin, Germany
Städtisches Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Universitäts Düsseldorf; Klinik für Anästhesiologie
🇩🇪Dusseldorf, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universität Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Jena; Zentrum für Infektionsmedizin
🇩🇪Jena, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Universitätsklinik Schleswig-Holstein
🇩🇪Lübeck, Germany
LMU München
🇩🇪München, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Klinikum Oldenburg
🇩🇪Oldenburg in Holstein, Germany
Universitätsklinik Regensburg; Klinik für Anästhesiologie
🇩🇪Regensburg, Germany
Kliniken Nordoberpfalz
🇩🇪Weiden, Germany
General Oncology Hospital of Kifissia "Agioi Anargiroi"
🇬🇷Kifissia, Athens, Greece
Sotiria Thoracic Diseases Hospital of Athens
🇬🇷Athens, Greece
General Hospital of Attica "KAT"
🇬🇷Kifissia, Greece
RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases
🇬🇷Patras, Greece
General Hospital of Thessaloniki "Hippokration"
🇬🇷Thessaloníki, Greece
Clinical Malattie Infettive
🇮🇹Bari, Italy
Azienda Ospedaliera S.Croce e Carle
🇮🇹Cuneo, Italy
Ospedal Policlinico San Martino
🇮🇹Genova, Italy
Ospedale L. Sacco
🇮🇹Mailand, Italy
Istituto Mediterraneo per i Trapianti Ismett IRCCS
🇮🇹Palermo, Italy
Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Policlinico Umberto I, Malattie Infettive
🇮🇹Rom, Italy
Lazzaro Spallanzani
🇮🇹Rom, Italy
Polocinico Tor Vergata
🇮🇹Rom, 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, United Kingdom
Hull & East Yorkshire Hospitals NHS Trust
🇬🇧Cottingham, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Queen Elisabeth University Hospital
🇬🇧Glasgow, United Kingdom
University of Glasgow/Royal Infirmary
🇬🇧Glasgow, United Kingdom
University Hospital Crosshouse
🇬🇧Kilmarnock, United Kingdom
Chelsea & Westminster Hospial
🇬🇧London, United Kingdom
Queen Elisabeth Hospital
🇬🇧London, United Kingdom
Univresity College Londen (UCL) Hospital
🇬🇧London, United Kingdom