Fosfomycin i.v. for Treatment of Severely Infected Patients (FORTRESS)

 Bacterial Meningitis / Posted 4 weeks ago

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.
  • Inclusion Criteria :
    • Male or female patients at least 18 years old
    • 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 more than 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
  • Study start date : December 2016
  • Study end date : December 2023
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Gavin Barlow, MD (Hull & East Yorkshire NHS Trust)
Contact details

Castle Hill Hospital, Cottingham, UK, England,HU16 5JQ  Show Phone Number www.hey.nhs.uk

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