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Fosfomycin I.v. for Treatment of Severely Infected Patients

Recruitingn/aAges 18 Years - anyAllInfectopharm Arzneimittel GmbH
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

50 sites
Landeskrankenhaus Hall - Tirol Kliniken
Hall in Tirol, Austria
A.ö. Bezirkskrankenhaus
Reutte, Austria
AKH Wien, Universitätsklinik für Innere Medizin 1
Vienna, Austria
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
Wels, Austria
Universitätsmedizin Charité
Berlin, Germany
Vivantes Kliniken Neukölln
Berlin, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Germany
Universitäts Düsseldorf; Klinik für Anästhesiologie
Düsseldorf, Germany

…and 42 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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