Fosfomycin I.v. for Treatment of Severely Infected Patients (FORTRESS)

September 27, 2024 updated by: Infectopharm Arzneimittel GmbH

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.

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Thomas Borrmann, Dr.
Email: Clinical.Trials@infectopharm.com

Study Contact Backup

Name: Katja Eifert
Email: Clinical.Trials@infectopharm.com

Study Locations

Austria
- - Hall In Tirol, Austria
    - Recruiting
    - Landeskrankenhaus Hall - Tirol Kliniken
    - Contact:
      
      Ivo Graziadei, MD
  - Reutte, Austria
    - Recruiting
    - A.ö. Bezirkskrankenhaus
    - Contact:
      
      Eugen Ladner, MD
  - Wels, Austria
    - Recruiting
    - Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
    - Contact:
      
      Rainer Gattringer, MD
  - Wien, Austria
    - Recruiting
    - AKH Wien, Universitätsklinik für Innere Medizin 1
    - Contact:
      
      Matthias Vossen, MD
Germany
- - Berlin, Germany, 12351
    - Recruiting
    - Vivantes Kliniken Neukölln
    - Contact:
      
      Herwig Gerlach, Prof.
  - Berlin, Germany, 10177
    - Completed
    - Universitätsmedizin Charité
  - Braunschweig, Germany, 38126
    - Recruiting
    - Städtisches Klinikum Braunschweig
    - Contact:
      
      Jan Kielstein, Dr.
  - Dusseldorf, Germany, 40225
    - Completed
    - Universitäts Düsseldorf; Klinik für Anästhesiologie
  - Frankfurt, Germany
    - Recruiting
    - Universitatsklinikum Frankfurt
    - Contact:
      
      Simone Lindau
  - Hamburg, Germany, 20251
    - Recruiting
    - Universität Hamburg-Eppendorf
    - Contact:
      
      Stefan Kluge, Prof.
  - Jena, Germany, 07740
    - Recruiting
    - Universitätsklinikum Jena; Zentrum für Infektionsmedizin
    - Contact:
      
      Mathias Pletz, Prof.
  - Kiel, Germany
    - Recruiting
    - Universitätsklinikum Schleswig-Holstein
    - Contact:
      
      Dirk Schädler, Prof.
  - Lübeck, Germany, 23538
    - Recruiting
    - Universitatsklinik Schleswig-Holstein
    - Contact:
      
      Jan Rupp, Prof.
  - München, Germany, 81377
    - Recruiting
    - LMU München
    - Contact:
      
      Michael Zoller, Dr.
  - Münster, Germany, 40149
    - Recruiting
    - Universitätsklinikum Münster
    - Contact:
      
      Sebastian Kintrup, MD
  - Oldenburg in Holstein, Germany
    - Recruiting
    - Klinikum Oldenburg
    - Contact:
      
      Ulf Günther, PD
  - Regensburg, Germany, 93053
    - Recruiting
    - Universitätsklinik Regensburg; Klinik für Anästhesiologie
    - Contact:
      
      Martin Kieninger, Dr. med.
  - Weiden, Germany, 92637
    - Completed
    - Kliniken Nordoberpfalz
Greece
- - Athens, Greece
    - Recruiting
    - General Hospital of Athens "Evangelismos"
    - Contact:
      
      Anastasia Kotanidou, MD
      
      Phone Number: +30 6974508199
      
      Email: akotanid@med.uoa.gr
  - Athens, Greece
    - Recruiting
    - University General Hospital "Attikon"
    - Contact:
      
      Evangelos I. Giamarellos, MD
      
      Phone Number: +30 6932905547
      
      Email: egiamarel@med.uoa.gr
  - Athens, Greece
    - Recruiting
    - Sotiria Thoracic Diseases Hospital of Athens
    - Contact:
      
      Georgios Dimopoulos, MD
  - Kifissia, Greece
    - Recruiting
    - General Hospital of Attica "KAT"
    - Contact:
      
      Ioannis Alamanos, MD
  - Lamia, Greece
    - Recruiting
    - General Hospital of Lamia
    - Contact:
      
      Fotios Tsimpoukas, MD
      
      Phone Number: +30 6932766976
      
      Email: ftsimpoukas@yahoo.gr
  - Patras, Greece
    - Recruiting
    - RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases
    - Contact:
      
      Markos Marangos, MD
  - Thessaloniki, Greece
    - Recruiting
    - "AHEPA" University General Hospital of Thessaloniki
    - Contact:
      
      Aikaterini Efthimiou, MD
      
      Phone Number: +30 6974091279
      
      Email: efthka@gmail.com
  - Thessaloniki, Greece
    - Recruiting
    - General Hospital of Thessaloniki "G. GENIMMATAS"
    - Contact:
      
      Areti Karapanagiotou, MD
      
      Email: aretikarapan@gmail.com
  - Thessaloníki, Greece
    - Recruiting
    - General Hospital of Thessaloniki "G. Papanikolaou"
    - Contact:
      
      Nikolaos Kapravelos, MD
  - Thessaloníki, Greece
    - Recruiting
    - General Hospital of Thessaloniki "Hippokration"
    - Contact:
      
      Eleni Mouloudi, MD
- Athens
  - Kifissia, Athens, Greece
    - Recruiting
    - General Oncology Hospital of Kifissia "Agioi Anargiroi"
    - Contact:
      
      Pavlos Myrianthefs, MD
Italy
- - Bari, Italy, 70124
    - Recruiting
    - Clinical Malattie Infettive
    - Contact:
      
      Davide Bavaro, MD
  - Cuneo, Italy
    - Recruiting
    - Azienda Ospedaliera S.Croce e Carle
    - Contact:
      
      Valerio Del Bono, MD
  - Genova, Italy
    - Recruiting
    - Ospedal Policlinico San Martino
    - Contact:
      
      Matteo Basetti, MD
  - Mailand, Italy
    - Active, not recruiting
    - Ospedale L. Sacco
  - Palermo, Italy
    - Recruiting
    - Policlinico Paolo Giaccone
    - Contact:
      
      Antonio Cascio, MD
  - Palermo, Italy
    - Recruiting
    - Istituto Mediterraneo per i Trapianti Ismett IRCCS
    - Contact:
      
      Alessandra Mularoni, MD
  - Rom, Italy, 00161
    - Recruiting
    - Policlinico Umberto I, Malattie Infettive
    - Contact:
      
      Mario Venditti, MD
  - Rom, Italy
    - Recruiting
    - Lazzaro Spallanzani
    - Contact:
      
      Alessandro Capone, MD
  - Rom, Italy
    - Recruiting
    - Polocinico Tor Vergata
    - Contact:
      
      Loredana Sarmati, MD
  - Torino, Italy
    - Recruiting
    - AOU Città della Salute e Scienza-Presidio Molinette
    - Contact:
      
      Francesco G. De Rosa, MD
  - Udine, Italy
    - Recruiting
    - Ospedale S.M.della Misericordia
    - Contact:
      
      Carlo Tascini, MD
  - Varese, Italy
    - Recruiting
    - ASST-Sette Lagh Viale Borre
    - Contact:
      
      Paolo A. Grossi, MD
United Kingdom
- - Bolton, United Kingdom, BL4 0JR
    - Active, not recruiting
    - Royal Bolton Hospital
  - Cottingham, United Kingdom, HU16 5JQ
    - Recruiting
    - Hull & East Yorkshire Hospitals NHS Trust
    - Contact:
      
      Gavin Barlow, MD
  - Dundee, United Kingdom, DD1 9SY
    - Recruiting
    - Ninewells Hospital
    - Contact:
      
      Benjamin Parcell, MD
  - Glasgow, United Kingdom
    - Recruiting
    - Queen Elisabeth University Hospital
    - Contact:
      
      Abhijit Bal, MD
  - Glasgow, United Kingdom
    - Recruiting
    - University of Glasgow/Royal Infirmary
    - Contact:
      
      Michael E Murphy, MD
  - Kilmarnock, United Kingdom, KA2OBB
    - Recruiting
    - University Hospital Crosshouse
    - Contact:
      
      Sam Allen, MD
  - London, United Kingdom
    - Recruiting
    - Queen Elisabeth Hospital
    - Contact:
      
      Jorge Cepeda, MD
  - London, United Kingdom
    - Recruiting
    - Chelsea & Westminster Hospial
    - Contact:
      
      Luke Moore, MD
  - London, United Kingdom
    - Recruiting
    - Univresity College Londen (UCL) Hospital
    - Contact:
      
      Giovanni Satta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

All patients of the participating study sites (clinics specialised and experienced in the management and treatment of patients suffering from (a part of) the included diseases as mentioned in the respective inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the exclusion criteria, are eligible for participation in the FORTRESS study.

Description

Inclusion Criteria:

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)

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 Immunodeficiency Syndrome, AIDS)
Fosfomycin treatment as 4th line treatment or at later stage
Patients with involvement of fungi or mycobacteria in the targeted infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with clinical success as defined as clinical cure or clinical improvement Time Frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)	Definition of clinical cure (both criteria must be fulfilled): Resolution of signs and symptoms and microbiological cure or no additional antibiotic therapy for the targeted infection necessary. Definition of clinical improvement (both criteria must be fulfilled): Partial resolution of signs and symptoms and microbiological cure or no additional antibiotic therapy for the targeted infection necessary. Definition of microbiological cure: Elimination of the relevant pathogen(s) at the relevant site(s) of infection (at least one negative culture) or in case "no sample available/indicated due to sufficient clinical response", pathogen elimination is considered. Time Frame: Time point "End of fosfomycin treatment" (EOT) is reached at the day of the last fosfomycin application in the course of the treatment schedule for the targeted infection (i.e., in case of a multiple stage treatment schedule, the end of the last fosfomycin treatment phase).	Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infectopharm Arzneimittel GmbH

Collaborators

INPADS GmbH

Dr. Oestreich + Partner GmbH

Investigators

Study Director: Klaus-Friedrich Bodmann, Dr., Klinik Nordoberpfalz AG, Klinikum Weiden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria