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NCT Number: NCT02979951

Fosfomycin I.v. for Treatment of Severely Infected Patients

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.

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Key information

Conditions

Bacterial Infections Abscess Bacteremia Bacterial Infections and Mycoses Bone Diseases Bone Diseases, Infectious Brain Abscess Brain Diseases Cardiovascular Diseases Cardiovascular Infections Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Encephalitis Endocarditis Endocarditis, Bacterial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Heart Diseases Infections Inflammation Intraabdominal Infections Lung Diseases Male Urogenital Diseases Meningitis Meningitis, Bacterial Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Osteomyelitis Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Sepsis Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Soft Tissue Infections Suppuration Systemic Inflammatory Response Syndrome Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landeskrankenhaus Hall - Tirol Kliniken, Hall in Tirol, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Katja Eifert

CONTACT

[email protected]

Thomas Borrmann, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Infectopharm Arzneimittel GmbH

Industry

Collaborators

  • Dr. Oestreich + Partner GmbH
  • INPADS GmbH

Registry information

Official study title

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.

Acronym: FORTRESS

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Dec 2, 2016
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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