Status:
RECRUITING
Fosfomycin I.v. for Treatment of Severely Infected Patients
Lead Sponsor:
Infectopharm Arzneimittel GmbH
Collaborating Sponsors:
INPADS GmbH
Dr. Oestreich + Partner GmbH
Conditions:
Bacterial Infections
Bone Diseases, Infectious
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02979951
Start Date
December 1 2016
End Date
December 1 2030
Last Update
October 1 2024
Active Locations (50)
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1
Landeskrankenhaus Hall - Tirol Kliniken
Hall in Tirol, Austria
2
A.ö. Bezirkskrankenhaus
Reutte, Austria
3
AKH Wien, Universitätsklinik für Innere Medizin 1
Vienna, Austria
4
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
Wels, Austria