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Fosfomycin i.v. for Treatment of Severely Infected Patients

Fosfomycin i.v. for Treatment of Severely Infected Patients

Recruiting
18 years and older
All
Phase N/A

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Overview

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 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

Study details
    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

NCT02979951

Infectopharm Arzneimittel GmbH

27 January 2024

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