Bacteremia, Bacterial Infections, Bone Diseases, Infectious, Brain Abscess, Central Nervous System Bacterial Infections, Encephalitis, Endocarditis, Bacterial, Intraabdominal Infections, Meningitis, Bacterial, Osteomyelitis, Pneumonia, Bacterial, Respiratory Tract Infections, Sepsis, Skin Diseases, Bacterial, Soft Tissue Infections, Urinary Tract Infections
Conditions
Keywords
Observational Study, Non-Interventional Study, Registries, Prospective, Monitored, Multicentric, International, Fosfomycin, Infectofos, Fomicyt, Bacterial Infections, Gram-Negative Bacterial Infections, Gram-Positive Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections, Meningitis, Bacterial, Encephalitis, Brain Abscess, Urinary Tract Infections, Respiratory Tract Infections, Pneumonia, Bacterial, Skin Diseases, Bacterial, Soft Tissue Infections, Intraabdominal Infections, Sepsis, Bacteremia, Endocarditis, Bacterial, Treatment Outcome, Clinical Efficacy, Microbiological Efficacy, Safety
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.
Interventions
None listed
Sponsors
INPADS GmbH
Dr. Oestreich + Partner GmbH
Infectopharm Arzneimittel GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical success as defined as clinical cure or clinical improvement | Analysed at initial response (not later than 7 days 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 initial response is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment. |
| Clinical cure | 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 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). |
| Clinical improvement | Analysed at initial response (not later than 7 days after start of fosfomycin treatment) | 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. |
| 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) | — |
| Adverse events | On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) | — |
| Microbiological cure | Analysed at initial response (not later than 7 days after start of fosfomycin treatment) | 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. |
| 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) | — |
| 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) | — |
| 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) | — |
| 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) | — |
| 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) | — |
| 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) | — |
Countries
Austria, Germany, Greece, Italy, United Kingdom
Contacts
Primary ContactThomas Borrmann, Dr.
Backup ContactKatja Eifert
Outcome results
None listed