An observational study in Bacterial Infections, Bone Diseases, Infectious and Osteomyelitis, sponsored by Infectopharm Arzneimittel GmbH. Recruiting at 50 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Infectopharm Arzneimittel GmbH · Observational
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.
665 studies on the registry are indexed under Bacterial Infections; 99 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 231 observational studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Infectopharm Arzneimittel GmbH is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Plan to share: No
The record gives a start of Dec 2016, a primary completion of Dec 2030 and a completion of Dec 2030. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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Infectopharm Arzneimittel GmbH