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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bacterial Infections
- Sponsor
- Infectopharm Arzneimittel GmbH
- Enrollment
- 1000
- Locations
- 50
- Primary Endpoint
- Percentage of patients with clinical success as defined as clinical cure or clinical improvement
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Percentage of patients with clinical success as defined as clinical cure or clinical improvement
Time Frame: 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 Outcomes
- 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))
- Microbiological cure(Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis"))
- 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))
- 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"))
- Clinical cure(Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis"))
- 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"))
- 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))
- 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))