Actively Recruiting

Age: 18Years +
All Genders
NCT02979951

Fosfomycin I.v. for Treatment of Severely Infected Patients

Led by Infectopharm Arzneimittel GmbH · Updated on 2024-10-01

1000

Participants Needed

50

Research Sites

730 weeks

Total Duration

On this page

Sponsors

I

Infectopharm Arzneimittel GmbH

Lead Sponsor

I

INPADS GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fosfomycin I.v. for Treatment of Severely Infected Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 63 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, as covered by the nationally relevant SmPC
  • Written informed consent of the participant or authorized person if participant is unable to consent
Not Eligible

You will not qualify if you...

  • Previous documentation of the patient in this study
  • Participation in an interventional clinical trial
  • Known hypersensitivity to fosfomycin or any excipients
  • Terminal illness
  • "Do not resuscitate" order
  • Palliative treatment approach
  • Failure of more than 3 organ systems: respiratory, nervous, cardiovascular, liver, coagulation, kidney
  • Manifest HIV disease (AIDS)
  • Fosfomycin used as fourth-line or later treatment
  • Infection involving fungi or mycobacteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 50 locations

1

Landeskrankenhaus Hall - Tirol Kliniken

Hall in Tirol, Austria

Actively Recruiting

2

A.ö. Bezirkskrankenhaus

Reutte, Austria

Actively Recruiting

3

AKH Wien, Universitätsklinik für Innere Medizin 1

Vienna, Austria

Actively Recruiting

4

Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie

Wels, Austria

Actively Recruiting

5

Universitätsmedizin Charité

Berlin, Germany, 10177

Completed

6

Vivantes Kliniken Neukölln

Berlin, Germany, 12351

Actively Recruiting

7

Städtisches Klinikum Braunschweig

Braunschweig, Germany, 38126

Actively Recruiting

8

Universitäts Düsseldorf; Klinik für Anästhesiologie

Düsseldorf, Germany, 40225

Completed

9

Universitätsklinikum Frankfurt

Frankfurt, Germany

Actively Recruiting

10

Universität Hamburg-Eppendorf

Hamburg, Germany, 20251

Actively Recruiting

11

Universitätsklinikum Jena; Zentrum für Infektionsmedizin

Jena, Germany, 07740

Actively Recruiting

12

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Actively Recruiting

13

Universitätsklinik Schleswig-Holstein

Lübeck, Germany, 23538

Actively Recruiting

14

LMU München

München, Germany, 81377

Actively Recruiting

15

Universitätsklinikum Münster

Münster, Germany, 40149

Actively Recruiting

16

Klinikum Oldenburg

Oldenburg in Holstein, Germany

Actively Recruiting

17

Universitätsklinik Regensburg; Klinik für Anästhesiologie

Regensburg, Germany, 93053

Actively Recruiting

18

Kliniken Nordoberpfalz

Weiden, Germany, 92637

Completed

19

General Oncology Hospital of Kifissia "Agioi Anargiroi"

Kifissia, Athens, Greece

Actively Recruiting

20

General Hospital of Athens "Evangelismos"

Athens, Greece

Actively Recruiting

21

Sotiria Thoracic Diseases Hospital of Athens

Athens, Greece

Actively Recruiting

22

University General Hospital "ATTIKON"

Athens, Greece

Actively Recruiting

23

General Hospital of Attica "KAT"

Kifissia, Greece

Actively Recruiting

24

General Hospital of Lamia

Lamia, Greece

Actively Recruiting

25

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

Pátrai, Greece

Actively Recruiting

26

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, Greece

Actively Recruiting

27

General Hospital of Thessaloniki "G. GENIMMATAS"

Thessaloniki, Greece

Actively Recruiting

28

General Hospital of Thessaloniki "Hippokration"

Thessaloniki, Greece

Actively Recruiting

29

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, Greece

Actively Recruiting

30

Clinical Malattie Infettive

Bari, Italy, 70124

Actively Recruiting

31

Azienda Ospedaliera S.Croce e Carle

Cuneo, Italy

Actively Recruiting

32

Ospedal Policlinico San Martino

Genova, Italy

Actively Recruiting

33

Ospedale L. Sacco

Milan, Italy

Active, Not Recruiting

34

Istituto Mediterraneo per i Trapianti Ismett IRCCS

Palermo, Italy

Actively Recruiting

35

Policlinico Paolo Giaccone

Palermo, Italy

Actively Recruiting

36

Policlinico Umberto I, Malattie Infettive

Rome, Italy, 00161

Actively Recruiting

37

Lazzaro Spallanzani

Rome, Italy

Actively Recruiting

38

Polocinico Tor Vergata

Rome, Italy

Actively Recruiting

39

AOU Città della Salute e Scienza-Presidio Molinette

Torino, Italy

Actively Recruiting

40

Ospedale S.M.della Misericordia

Udine, Italy

Actively Recruiting

41

ASST-Sette Lagh Viale Borre

Varese, Italy

Actively Recruiting

42

Royal Bolton Hospital

Bolton, United Kingdom, BL4 0JR

Active, Not Recruiting

43

Hull & East Yorkshire Hospitals NHS Trust

Cottingham, United Kingdom, HU16 5JQ

Actively Recruiting

44

Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Actively Recruiting

45

Queen Elisabeth University Hospital

Glasgow, United Kingdom

Actively Recruiting

46

University of Glasgow/Royal Infirmary

Glasgow, United Kingdom

Actively Recruiting

47

University Hospital Crosshouse

Kilmarnock, United Kingdom, KA2OBB

Actively Recruiting

48

Chelsea & Westminster Hospial

London, United Kingdom

Actively Recruiting

49

Queen Elisabeth Hospital

London, United Kingdom

Actively Recruiting

50

Univresity College Londen (UCL) Hospital

London, United Kingdom

Actively Recruiting

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Research Team

T

Thomas Borrmann, Dr.

CONTACT

K

Katja Eifert

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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