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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Landeskrankenhaus Hall - Tirol Kliniken
Hall in Tirol, Austria
RECRUITINGA.ö. Bezirkskrankenhaus
Reutte, Austria
RECRUITINGAKH Wien, Universitätsklinik für Innere Medizin 1
Vienna, Austria
RECRUITINGKlinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
Wels, Austria
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).
Time frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Microbiological cure
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 "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
Time frame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
Microbiological cure
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).
Time frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Microbiological cure
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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Time frame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
Microbiological cure
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.
Time frame: 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): * 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 "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
Time frame: 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): * 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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Time frame: 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): * 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.
Time frame: 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): * 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).
Time frame: 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): * 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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Time frame: 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): * 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.
Time frame: 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): * 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 "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.
Time frame: 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): * 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).
Time frame: 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): * 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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.
Time frame: 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): * 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.
Time frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
Sodium serum levels
Time frame: 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
Time frame: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)
Adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsmedizin Charité
Berlin, Germany
COMPLETEDVivantes Kliniken Neukölln
Berlin, Germany
RECRUITINGStädtisches Klinikum Braunschweig
Braunschweig, Germany
RECRUITINGUniversitäts Düsseldorf; Klinik für Anästhesiologie
Düsseldorf, Germany
COMPLETEDUniversitätsklinikum Frankfurt
Frankfurt, Germany
RECRUITINGUniversität Hamburg-Eppendorf
Hamburg, Germany
RECRUITING...and 40 more locations