Fosfomycin I.v. for Treatment of Severely Infected Patients
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.
Infectopharm Arzneimittel GmbH
1,000 participants
Dec 1, 2016
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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
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Locations(50)
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NCT02979951