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

  • STATUS
    Recruiting
  • End date
    Dec 8, 2023
  • participants needed
    1000
  • sponsor
    Infectopharm Arzneimittel GmbH
Updated on 27 January 2022
sepsis
urinary tract infection
endocarditis
bacteremia
osteomyelitis
lower respiratory tract infection
fosfomycin
soft tissue infection
bacterial infection
meningitis
septicemia
bacterial meningitis
respiratory tract infection
bacterial infections
nosocomial infections
bacteraemia
neurologic finding
central nervous system infection
complicated urinary tract infection
infection, nosocomial

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.

Details
Condition 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
Clinical Study IdentifierNCT02979951
SponsorInfectopharm Arzneimittel GmbH
Last Modified on27 January 2022

Eligibility

Yes No Not Sure

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
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