Clinical trial NCT02979951: Fosfomycin I.v. for Treatment of Severely Infected Patients
Official 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: 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
Microbiological Efficacy
Safety
Lead sponsor: Infectopharm Arzneimittel GmbH
Sponsor class: INDUSTRY
Collaborators: name: INPADS GmbH
name: Dr. Oestreich + Partner GmbH
First posted: 2016-12-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Percentage of patients with clinical success as defined as clinical cure or clinical improvement
timeFrame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
Secondary outcomes:
measure: Microbiological cure
timeFrame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
measure: Microbiological cure
timeFrame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
measure: Microbiological cure
timeFrame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
measure: Microbiological cure
timeFrame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
measure: Clinical success as defined as clinical cure or clinical improvement
timeFrame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
measure: Clinical success as defined as clinical cure or clinical improvement
timeFrame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
measure: Clinical success as defined as clinical cure or clinical improvement
timeFrame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
measure: Clinical cure
timeFrame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
measure: Clinical cure
timeFrame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
measure: Clinical cure
timeFrame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
measure: Clinical improvement
timeFrame: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)
measure: Clinical improvement
timeFrame: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)
measure: Clinical improvement
timeFrame: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)
measure: Clinical improvement
timeFrame: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")
measure: Sodium serum levels
timeFrame: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)
measure: Potassium serum levels
timeFrame: On every day from start of fosfomycin treatment until end of hospital stay (up to 6 months after start of fosfomycin treatment)
measure: Adverse events
timeFrame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Non-serious adverse events
timeFrame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Serious adverse events
timeFrame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Cases of death
timeFrame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Adverse drug reactions (ADRs)
timeFrame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Serious adverse drug reactions (SADRs)
timeFrame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
measure: Dropouts due to treatment failure or due to adverse events
timeFrame: On every day from start of fosfomycin treatment until end of follow-up (up to one year after start of fosfomycin treatment)
Other outcomes:
Locations:
city: Hall In Tirol
country: Austria
facility: Landeskrankenhaus Hall - Tirol Kliniken
city: Reutte
country: Austria
facility: A.ö. Bezirkskrankenhaus
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
city: Wien
country: Austria
facility: AKH Wien, Universitätsklinik für Innere Medizin 1
city: Berlin
country: Germany
facility: Universitätsmedizin Charité
city: Berlin
country: Germany
facility: Vivantes Kliniken Neukölln
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
city: Dusseldorf
country: Germany
facility: Universitäts Düsseldorf; Klinik für Anästhesiologie
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Universität Hamburg-Eppendorf
city: Jena
country: Germany
facility: Universitätsklinikum Jena; Zentrum für Infektionsmedizin
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinik Schleswig-Holstein
city: München
country: Germany
facility: LMU München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Oldenburg in Holstein
country: Germany
facility: Klinikum Oldenburg
city: Regensburg
country: Germany
facility: Universitätsklinik Regensburg; Klinik für Anästhesiologie
city: Weiden
country: Germany
facility: Kliniken Nordoberpfalz
city: Kifissia
country: Greece
facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"
state: Athens
city: Athens
country: Greece
facility: General Hospital of Athens &#34;Evangelismos&#34;
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens
city: Athens
country: Greece
facility: University General Hospital "ATTIKON"
city: Kifissia
country: Greece
facility: General Hospital of Attica "KAT"
city: Lamia
country: Greece
facility: General Hospital of Lamia
city: Patras
country: Greece
facility: RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases
city: Thessaloniki
country: Greece
facility: "AHEPA" University General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. GENIMMATAS"
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki "Hippokration"
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki &#34;G. Papanikolaou&#34;
city: Bari
country: Italy
facility: Clinical Malattie Infettive
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S.Croce e Carle
city: Genova
country: Italy
facility: Ospedal Policlinico San Martino
city: Mailand
country: Italy
facility: Ospedale L. Sacco
city: Palermo
country: Italy
facility: Istituto Mediterraneo per i Trapianti Ismett IRCCS
city: Palermo
country: Italy
facility: Policlinico Paolo Giaccone
city: Rom
country: Italy
facility: Policlinico Umberto I, Malattie Infettive
city: Rom
country: Italy
facility: Lazzaro Spallanzani
city: Rom
country: Italy
facility: Polocinico Tor Vergata
city: Torino
country: Italy
facility: AOU Città della Salute e Scienza-Presidio Molinette
city: Udine
country: Italy
facility: Ospedale S.M.della Misericordia
city: Varese
country: Italy
facility: ASST-Sette Lagh Viale Borre
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Cottingham
country: United Kingdom
facility: Hull & East Yorkshire Hospitals NHS Trust
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elisabeth University Hospital
city: Glasgow
country: United Kingdom
facility: University of Glasgow/Royal Infirmary
city: Kilmarnock
country: United Kingdom
facility: University Hospital Crosshouse
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospial
city: London
country: United Kingdom
facility: Queen Elisabeth Hospital
city: London
country: United Kingdom
facility: Univresity College Londen (UCL) Hospital
Study officials:
affiliation: Klinik Nordoberpfalz AG, Klinikum Weiden
name: Klaus-Friedrich Bodmann, Dr.
role: STUDY_DIRECTOR
References: