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Recruiting NCT02979951

Fosfomycin I.v. for Treatment of Severely Infected Patients

Trial Parameters

Condition Bacterial Infections
Sponsor Infectopharm Arzneimittel GmbH
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2016-12
Completion 2030-12

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.

Eligibility Criteria

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 sy

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