Using fosfomycin to treat severely infected patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This European, multicentric, prospective, non-interventional study aims to document and evaluate the efficacy and safety of intravenously administered fosfomycin in severely infected patients. It includes individuals suffering from various serious infections such as osteomyelitis, complicated urinary tract infections, and bacterial meningitis. The study will monitor patients receiving fosfomycin treatment according to national guidelines, focusing on real-world outcomes. Data will be collected to assess the effectiveness and safety of this treatment approach in a diverse patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Landeskrankenhaus Hall - Tirol Kliniken
  Hall in Tirol, Austria Recruiting
• A.ö. Bezirkskrankenhaus
  Reutte, Austria Recruiting
• AKH Wien, Universitätsklinik für Innere Medizin 1
  Vienna, Austria Recruiting
• Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
  Wels, Austria Recruiting
• Vivantes Kliniken Neukölln
  Berlin, Germany Recruiting
• Städtisches Klinikum Braunschweig
  Braunschweig, Germany Recruiting

Study contacts

• Study coordinator: Thomas Borrmann, Dr.
• Email: Clinical.Trials@infectopharm.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.