Health Trials

Fosfomycin I.v. for Treatment of Severely Infected Patients

ConditionsBacterial InfectionsBone Diseases, InfectiousOsteomyelitisCentral Nervous System Bacterial InfectionsMeningitis, BacterialEncephalitisBrain AbscessUrinary Tract InfectionsRespiratory Tract InfectionsPneumonia, BacterialSkin Diseases, BacterialSoft Tissue InfectionsIntraabdominal InfectionsSepsisBacteremiaEndocarditis, Bacterial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInfectopharm Arzneimittel GmbH

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

50
Austria
Landeskrankenhaus Hall - Tirol Kliniken Hall in Tirol Austria
A.ö. Bezirkskrankenhaus Reutte Austria
AKH Wien, Universitätsklinik für Innere Medizin 1 Vienna Austria
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie Wels Austria

Sponsors and collaborators

Infectopharm Arzneimittel GmbH

Lead sponsor

INPADS GmbH

Collaborator

Dr. Oestreich + Partner GmbH

Collaborator

Source ClinicalTrials.gov