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

InfectoPharm

Status: Enrolling

Conditions: Central Nervous System Bacterial Infections; Urinary Tract Infections; Skin Diseases, Bacterial; Endocarditis, Bacterial; Meningitis, Bacterial; Encephalitis; Osteomyelitis; Soft Tissue Infections; Sepsis; Bacterial Infections; Intraabdominal Infections; Bacteremia; Brain Abscess; Respiratory Tract Infections; Bone Diseases, Infectious; Pneumonia, Bacterial

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02979951

FORTRESS

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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