Fosfomycin I.v. for Treatment of Severely Infected Patients

Last updated: September 27, 2024
Sponsor: Infectopharm Arzneimittel GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bacterial Infections

Urinary Tract Infections

Pneumonia

Treatment

N/A

Clinical Study ID

NCT02979951
FORTRESS
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients aged ≥ 18 years

  • Treatment with fosfomycin according to the (national) Summary of ProductCharacteristics (SmPC) of fosfomycin i.v.

  • Patients with osteomyelitis, complicated urinary tract infection, nosocomial lowerrespiratory 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 patientsincapable of giving consent)

Exclusion

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 ImmunodeficiencySyndrome, AIDS)

  • Fosfomycin treatment as 4th line treatment or at later stage

  • Patients with involvement of fungi or mycobacteria in the targeted infection

Study Design

Total Participants: 1000
Study Start date:
December 01, 2016
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Landeskrankenhaus Hall - Tirol Kliniken

    Hall In Tirol,
    Austria

    Active - Recruiting

  • A.ö. Bezirkskrankenhaus

    Reutte,
    Austria

    Active - Recruiting

  • Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie

    Wels,
    Austria

    Active - Recruiting

  • AKH Wien, Universitätsklinik für Innere Medizin 1

    Wien,
    Austria

    Active - Recruiting

  • Universitätsmedizin Charité

    Berlin, 10177
    Germany

    Completed

  • Vivantes Kliniken Neukölln

    Berlin, 12351
    Germany

    Active - Recruiting

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38126
    Germany

    Active - Recruiting

  • Universitäts Düsseldorf; Klinik für Anästhesiologie

    Dusseldorf, 40225
    Germany

    Completed

  • Universitätsklinikum Frankfurt

    Frankfurt,
    Germany

    Active - Recruiting

  • Universität Hamburg-Eppendorf

    Hamburg, 20251
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena; Zentrum für Infektionsmedizin

    Jena, 07740
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Kiel,
    Germany

    Active - Recruiting

  • Universitätsklinik Schleswig-Holstein

    Lübeck, 23538
    Germany

    Active - Recruiting

  • LMU München

    München, 81377
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, 40149
    Germany

    Active - Recruiting

  • Klinikum Oldenburg

    Oldenburg in Holstein,
    Germany

    Active - Recruiting

  • Universitätsklinik Regensburg; Klinik für Anästhesiologie

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Kliniken Nordoberpfalz

    Weiden, 92637
    Germany

    Completed

  • General Oncology Hospital of Kifissia "Agioi Anargiroi"

    Kifissia, Athens
    Greece

    Active - Recruiting

  • General Hospital of Athens "Evangelismos"

    Athens,
    Greece

    Active - Recruiting

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens,
    Greece

    Active - Recruiting

  • University General Hospital "ATTIKON"

    Athens,
    Greece

    Active - Recruiting

  • General Hospital of Attica "KAT"

    Kifissia,
    Greece

    Active - Recruiting

  • General Hospital of Lamia

    Lamia,
    Greece

    Active - Recruiting

  • RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases

    Patras,
    Greece

    Active - Recruiting

  • Uniersity General Hospital of Patras "Panagia Voithia"

    Patras,
    Greece

    Active - Recruiting

  • "AHEPA" University General Hospital of Thessaloniki

    Thessaloniki,
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki "G. GENIMMATAS"

    Thessaloniki,
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloníki,
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki "Hippokration"

    Thessaloníki,
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloníki,
    Greece

    Active - Recruiting

  • Clinical Malattie Infettive

    Bari, 70124
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S.Croce e Carle

    Cuneo,
    Italy

    Active - Recruiting

  • Ospedal Policlinico San Martino

    Genova,
    Italy

    Active - Recruiting

  • Ospedale L. Sacco

    Mailand,
    Italy

    Site Not Available

  • Istituto Mediterraneo per i Trapianti Ismett IRCCS

    Palermo,
    Italy

    Active - Recruiting

  • Policlinico Paolo Giaccone

    Palermo,
    Italy

    Active - Recruiting

  • Lazzaro Spallanzani

    Rom,
    Italy

    Active - Recruiting

  • Policlinico Umberto I, Malattie Infettive

    Rom, 00161
    Italy

    Active - Recruiting

  • Polocinico Tor Vergata

    Rom,
    Italy

    Active - Recruiting

  • AOU Città della Salute e Scienza-Presidio Molinette

    Torino,
    Italy

    Active - Recruiting

  • Ospedale S.M.della Misericordia

    Udine,
    Italy

    Active - Recruiting

  • ASST-Sette Lagh Viale Borre

    Varese,
    Italy

    Active - Recruiting

  • Royal Bolton Hospital

    Bolton, BL4 0JR
    United Kingdom

    Site Not Available

  • Hull & East Yorkshire Hospitals NHS Trust

    Cottingham, HU16 5JQ
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • Queen Elisabeth University Hospital

    Glasgow,
    United Kingdom

    Active - Recruiting

  • University of Glasgow/Royal Infirmary

    Glasgow,
    United Kingdom

    Active - Recruiting

  • University Hospital Crosshouse

    Kilmarnock, KA2OBB
    United Kingdom

    Active - Recruiting

  • Chelsea & Westminster Hospial

    London,
    United Kingdom

    Active - Recruiting

  • Queen Elisabeth Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Univresity College Londen (UCL) Hospital

    London,
    United Kingdom

    Active - Recruiting

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