Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT02979951
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02979951
Study Brief:
Protocol Section:
NCT02979951