Fosfomycin I.v. for Treatment of Severely Infected Patients
Recruiting now
Conditions studied: Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections, Meningitis, Bacterial, Encephalitis, Brain Abscess, Urinary Tract Infections, Respiratory Tract Infections, Pneumonia, Bacterial, Skin Diseases, Bacterial, Soft Tissue Infections, Intraabdominal Infections, Sepsis, Bacteremia, Endocarditis, Bacterial
In brief
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.
Key facts
- Study ID
- NCT02979951
- Run by
- Infectopharm Arzneimittel GmbH
- People needed
- 1000
- Starts
- 2016-12-01
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Clinical Malattie Infettive — Bari, Italy (enrolling)
- Ospedal Policlinico San Martino — Genova, Italy (enrolling)
- RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases — Pátrai, Greece (enrolling)
- "AHEPA" University General Hospital of Thessaloniki — Thessaloniki, Greece (enrolling)
- General Hospital of Thessaloniki "G. GENIMMATAS" — Thessaloniki, Greece (enrolling)
- General Hospital of Thessaloniki "G. Papanikolaou" — Thessaloniki, Greece (enrolling)
- Azienda Ospedaliera S.Croce e Carle — Cuneo, Italy (enrolling)
- Istituto Mediterraneo per i Trapianti Ismett IRCCS — Palermo, Italy (enrolling)
- Policlinico Paolo Giaccone — Palermo, Italy (enrolling)
- Policlinico Umberto I, Malattie Infettive — Rome, Italy (enrolling)
- Lazzaro Spallanzani — Rome, Italy (enrolling)
- Polocinico Tor Vergata — Rome, Italy (enrolling)
- AOU Città della Salute e Scienza-Presidio Molinette — Torino, Italy (enrolling)
- Ospedale S.M.della Misericordia — Udine, Italy (enrolling)
- ASST-Sette Lagh Viale Borre — Varese, Italy (enrolling)
- Hull & East Yorkshire Hospitals NHS Trust — Cottingham, United Kingdom (enrolling)
- Ninewells Hospital — Dundee, United Kingdom (enrolling)
- Queen Elisabeth University Hospital — Glasgow, United Kingdom (enrolling)
- University of Glasgow/Royal Infirmary — Glasgow, United Kingdom (enrolling)
- University Hospital Crosshouse — Kilmarnock, United Kingdom (enrolling)
- Chelsea & Westminster Hospial — London, United Kingdom (enrolling)
- Queen Elisabeth Hospital — London, United Kingdom (enrolling)
- Univresity College Londen (UCL) Hospital — London, United Kingdom (enrolling)
- General Hospital of Thessaloniki "Hippokration" — Thessaloniki, Greece (enrolling)
- Landeskrankenhaus Hall - Tirol Kliniken — Hall in Tirol, Austria (enrolling)
Full record on ClinicalTrials.gov
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