Clinical Trial: Fosfomycin i.v. for Treatment of Severely Infected Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
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
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 Summary:
Sponsor: Infectopharm Arzneimittel GmbH
Current Primary Outcome: 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: Same as current
Current Secondary Outcome:
- 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:&
Original Secondary Outcome: Same as current
Information By: Infectopharm Arzneimittel GmbH
Dates:
Date Received: November 24, 2016
Date Started: December 2016
Date Completion: June 2020
Last Updated: February 28, 2017
Last Verified: February 2017
