Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02979951
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : April 15, 2019
Sponsor:
Collaborators:
INPADS GmbH
Dr. Oestreich + Partner GmbH
Information provided by (Responsible Party):
Infectopharm Arzneimittel GmbH

Brief 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.

Condition or disease
Bacterial Infections Bone Diseases, Infectious Osteomyelitis Central Nervous System Bacterial Infections Meningitis, Bacterial Encephalitis Brain Abscess Urinary Tract Infections Respiratory Tract Infections Pneumonia, Bacterial Skin Diseases, Bacterial Soft Tissue Infections Intraabdominal Infections Sepsis Bacteremia Endocarditis, Bacterial

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A European, 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.
Study Start Date : December 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020





Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. Microbiological cure [ Time Frame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment) ]

    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 "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.


  2. Microbiological cure [ Time Frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment) ]

    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).


  3. Microbiological cure [ Time Frame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment) ]

    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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.


  4. Microbiological cure [ Time Frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") ]

    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:

    Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.


  5. Clinical success as defined as clinical cure or clinical improvement [ Time Frame: Analysed at "initial response" (not later than 7 days 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 "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.


  6. Clinical success as defined as clinical cure or clinical improvement [ Time Frame: Analysed at TOC ("Test of cure", 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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.


  7. Clinical success as defined as clinical cure or clinical improvement [ Time Frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") ]

    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:

    Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.


  8. Clinical cure [ 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 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).


  9. Clinical cure [ Time Frame: Analysed at TOC ("Test of cure", 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 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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.


  10. Clinical cure [ Time Frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") ]

    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 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:

    Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.


  11. Clinical improvement [ Time Frame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment) ]

    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 "initial response" is defined to be after start of fosfomycin treatment and not later than 7 days after start of fosfomycin treatment.


  12. Clinical improvement [ Time Frame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment) ]

    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).


  13. Clinical improvement [ Time Frame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment) ]

    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 "TOC" is defined to be not earlier than EOT and not later than end of hospital stay of the patient.


  14. Clinical improvement [ Time Frame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis") ]

    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:

    Defined to be after end of hospital stay + within 1 year after start of fosfomycin treatment. Either the latest visit after "End of hospital stay" within 1 year after start of fosfomycin treatment or, if applicable, the visit in this time frame assessing a clinical failure/relapse.


  15. Sodium serum levels [ Time Frame: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment) ]
  16. Potassium serum levels [ Time Frame: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment) ]
  17. Adverse events [ Time Frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) ]
  18. Non-serious adverse events [ Time Frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) ]
  19. Serious adverse events [ Time Frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) ]
  20. Cases of death [ Time Frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) ]
  21. Adverse drug reactions (ADRs) [ Time Frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) ]
  22. Serious adverse drug reactions (SADRs) [ Time Frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) ]
  23. Dropouts due to treatment failure or due to adverse events [ Time Frame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979951


Contacts
Layout table for location contacts
Contact: Thomas Borrmann, Dr. studien@infectopharm.com
Contact: Katja Eifert studien@infectopharm.com

Locations
Layout table for location information
Germany
Universitätsmedizin Charité Recruiting
Berlin, Germany, 10177
Contact: Claudia Spieß, Prof.         
Vivantes Kliniken Neukölln Recruiting
Berlin, Germany, 12351
Contact: Herwig Gerlach, Prof.         
Städtisches Klinikum Braunschweig Recruiting
Braunschweig, Germany, 38126
Contact: Jan Kielstein, Dr.         
Universitäts Düsseldorf; Klinik für Anästhesiologie Recruiting
Dusseldorf, Germany, 40225
Contact: Detlef Kindgen-Milles, Prof.         
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany
Contact: Patrick Meybohm, Prof.         
Universität Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20251
Contact: Stefan Kluge, Prof.         
Universitätsklinikum Jena; Zentrum für Infektionsmedizin Recruiting
Jena, Germany, 07740
Contact: Mathias Pletz, Prof.         
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany
Contact: Norbert Weiler, Prof.         
LMU München Recruiting
München, Germany, 81377
Contact: Michael Zoller, Dr.         
Klinikum Oldenburg Recruiting
Oldenburg in Holstein, Germany
Contact: Andreas Weyland, Prof.         
Universitätsklinik Regensburg; Klinik für Anästhesiologie Recruiting
Regensburg, Germany, 93053
Contact: Martin Kieninger, Dr. med.         
Kliniken Nordoberpfalz Recruiting
Weiden, Germany, 92637
Contact: Andreas Faltlhauser, Dr.         
Italy
Policlinico Umberto I, Malattie Infettive Active, not recruiting
Rom, Italy, 00161
United Kingdom
Royal Bolton Hospital Active, not recruiting
Bolton, United Kingdom, BL4 0JR
Hull & East Yorkshire Hospitals NHS Trust Active, not recruiting
Cottingham, United Kingdom, HU16 5JQ
Ninewells Hospital Active, not recruiting
Dundee, United Kingdom, DD1 9SY
University Hospital Crosshouse Recruiting
Kilmarnock, United Kingdom, KA2OBB
Contact: Abhijit Bal, MD         
Sponsors and Collaborators
Infectopharm Arzneimittel GmbH
INPADS GmbH
Dr. Oestreich + Partner GmbH
Investigators
Layout table for investigator information
Study Director: Klaus-Friedrich Bodmann, Dr. Head physician, Klinik für Internistische Intensiv- und Notfallmedizin und Klinische Infektiologie, Eberswalde, Germany

Layout table for additonal information
Responsible Party: Infectopharm Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT02979951     History of Changes
Other Study ID Numbers: FORTRESS
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: July 2017

Keywords provided by Infectopharm Arzneimittel GmbH:
Observational Study
Non-Interventional Study
Registries
Prospective
Monitored
Multicentric
International
Fosfomycin
Infectofos
Fomicyt
Bacterial Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Bone Diseases, Infectious
Osteomyelitis
Central Nervous System Bacterial Infections
Meningitis, Bacterial
Encephalitis
Brain Abscess
Urinary Tract Infections
Respiratory Tract Infections
Pneumonia, Bacterial
Skin Diseases, Bacterial
Soft Tissue Infections
Intraabdominal Infections
Sepsis
Bacteremia
Endocarditis, Bacterial
Treatment Outcome
Clinical Efficacy

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Pneumonia
Sepsis
Urinary Tract Infections
Meningitis
Respiratory Tract Infections
Bacterial Infections
Bacteremia
Encephalitis
Abscess
Skin Diseases
Bone Diseases
Endocarditis
Osteomyelitis
Soft Tissue Infections
Pneumonia, Bacterial
Intraabdominal Infections
Skin Diseases, Bacterial
Meningitis, Bacterial
Bone Diseases, Infectious
Endocarditis, Bacterial
Brain Abscess
Central Nervous System Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Urologic Diseases