An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.

Status: Recruiting
Location: See all (50) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Austria
Landeskrankenhaus Hall - Tirol Kliniken
RECRUITING
Hall In Tirol
A.ö. Bezirkskrankenhaus
RECRUITING
Reutte
AKH Wien, Universitätsklinik für Innere Medizin 1
RECRUITING
Vienna
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
RECRUITING
Wels
Germany
Universitätsmedizin Charité
COMPLETED
Berlin
Vivantes Kliniken Neukölln
RECRUITING
Berlin
Städtisches Klinikum Braunschweig
RECRUITING
Braunschweig
Universitäts Düsseldorf; Klinik für Anästhesiologie
COMPLETED
Düsseldorf
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt
Universität Hamburg-Eppendorf
RECRUITING
Hamburg
Universitätsklinikum Jena; Zentrum für Infektionsmedizin
RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
Universitätsklinik Schleswig-Holstein
RECRUITING
Lübeck
LMU München
RECRUITING
München
Universitätsklinikum Münster
RECRUITING
Münster
Klinikum Oldenburg
RECRUITING
Oldenburg In Holstein
Universitätsklinik Regensburg; Klinik für Anästhesiologie
RECRUITING
Regensburg
Kliniken Nordoberpfalz
COMPLETED
Weiden
Greece
General Hospital of Athens "Evangelismos"
RECRUITING
Athens
Sotiria Thoracic Diseases Hospital of Athens
RECRUITING
Athens
University General Hospital ATTIKON
RECRUITING
Athens
General Hospital of Attica KAT
RECRUITING
Kifissia
General Oncology Hospital of Kifissia Agioi Anargiroi
RECRUITING
Kifissia
General Hospital of Lamia
RECRUITING
Lamia
RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases
RECRUITING
Pátrai
AHEPA University General Hospital of Thessaloniki
RECRUITING
Thessaloniki
General Hospital of Thessaloniki "G. Papanikolaou"
RECRUITING
Thessaloniki
General Hospital of Thessaloniki G. GENIMMATAS
RECRUITING
Thessaloniki
General Hospital of Thessaloniki Hippokration
RECRUITING
Thessaloniki
Italy
Clinical Malattie Infettive
RECRUITING
Bari
Azienda Ospedaliera S.Croce e Carle
RECRUITING
Cuneo
Ospedal Policlinico San Martino
RECRUITING
Genova
Ospedale L. Sacco
ACTIVE_NOT_RECRUITING
Milan
Istituto Mediterraneo per i Trapianti Ismett IRCCS
RECRUITING
Palermo
Policlinico Paolo Giaccone
RECRUITING
Palermo
Lazzaro Spallanzani
RECRUITING
Rome
Policlinico Umberto I, Malattie Infettive
RECRUITING
Rome
Polocinico Tor Vergata
RECRUITING
Rome
AOU Città della Salute e Scienza-Presidio Molinette
RECRUITING
Torino
Ospedale S.M.della Misericordia
RECRUITING
Udine
ASST-Sette Lagh Viale Borre
RECRUITING
Varese
United Kingdom
Royal Bolton Hospital
ACTIVE_NOT_RECRUITING
Bolton
Hull & East Yorkshire Hospitals NHS Trust
RECRUITING
Cottingham
Ninewells Hospital
RECRUITING
Dundee
Queen Elisabeth University Hospital
RECRUITING
Glasgow
University of Glasgow/Royal Infirmary
RECRUITING
Glasgow
University Hospital Crosshouse
RECRUITING
Kilmarnock
Chelsea & Westminster Hospial
RECRUITING
London
Queen Elisabeth Hospital
RECRUITING
London
Univresity College Londen (UCL) Hospital
RECRUITING
London
Contact Information
Primary
Thomas Borrmann, Dr.
Clinical.Trials@infectopharm.com
Backup
Katja Eifert
Clinical.Trials@infectopharm.com
Time Frame
Start Date: 2016-12
Estimated Completion Date: 2030-12
Participants
Target number of participants: 1000
Sponsors
Collaborators: Dr. Oestreich + Partner GmbH, INPADS GmbH
Leads: Infectopharm Arzneimittel GmbH

This content was sourced from clinicaltrials.gov