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

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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

Tracking Information
First Submitted Date November 24, 2016
First Posted Date December 2, 2016
Last Update Posted Date April 15, 2019
Study Start Date December 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2016)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02979951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 1, 2016)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fosfomycin i.v. for Treatment of Severely Infected Patients
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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 1, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Thomas Borrmann, Dr. studien@infectopharm.com
Contact: Katja Eifert studien@infectopharm.com
Listed Location Countries Germany,   Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02979951
Other Study ID Numbers FORTRESS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Infectopharm Arzneimittel GmbH
Study Sponsor Infectopharm Arzneimittel GmbH
Collaborators
  • INPADS GmbH
  • Dr. Oestreich + Partner GmbH
Investigators
Study Director: Klaus-Friedrich Bodmann, Dr. Head physician, Klinik für Internistische Intensiv- und Notfallmedizin und Klinische Infektiologie, Eberswalde, Germany
PRS Account Infectopharm Arzneimittel GmbH
Verification Date July 2017