Fosfomycin I.v. for Treatment of Severely Infected Patients

Launched by INFECTOPHARM ARZNEIMITTEL GMBH · Dec 1, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called fosfomycin, given through an IV, to treat patients with severe bacterial infections. These infections can include serious conditions like bone infections, urinary tract infections, meningitis (an infection of the brain and spinal cord), and sepsis (a life-threatening response to infection). The goal of the study is to see how effective and safe fosfomycin is for these patients.

To participate in this trial, you must be at least 18 years old and have one of the specific infections mentioned. Additionally, you need to be able to give your written consent to join the study. If you decide to participate, you will receive fosfomycin under the supervision of medical professionals, and your health will be closely monitored throughout the treatment. It's important to note that some patients, such as those with severe organ failure or certain other health conditions, may not be eligible to join. Overall, this trial aims to gather more information about how fosfomycin can help those with serious infections.

Gender

ALL

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