Health TrialsbyHealthPanel

Fosfomycin I.v. for Treatment of Severely Infected Patients

ConditionsBacterial InfectionsBone Diseases, InfectiousOsteomyelitisCentral Nervous System Bacterial InfectionsMeningitis, BacterialEncephalitisBrain AbscessUrinary Tract InfectionsRespiratory Tract InfectionsPneumonia, BacterialSkin Diseases, BacterialSoft Tissue InfectionsIntraabdominal InfectionsSepsisBacteremiaEndocarditis, Bacterial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInfectopharm Arzneimittel GmbH

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Percentage of patients with clinical success as defined as clinical cure or clinical improvement

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).

Time frame
Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)

Secondary outcomes

1

Microbiological cure

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.

Time frame
Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
2

Microbiological cure

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).

Time frame
Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
3

Microbiological cure

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.

Time frame
Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
4

Microbiological cure

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.

Time frame
Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Infectopharm Arzneimittel GmbH

Lead sponsor

INPADS GmbH

Collaborator

Dr. Oestreich + Partner GmbH

Collaborator

Source ClinicalTrials.gov
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