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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 50
- 主要终点
- Percentage of patients with clinical success as defined as clinical cure or clinical improvement
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Percentage of patients with clinical success as defined as clinical cure or clinical improvement
时间窗: 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).
次要结局
- 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))