Fosfomycin I.v. for Treatment of Severely Infected Patients

Официальное название

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.

Обзор

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.

Первичные конечные точки

• Percentage of patients with clinical success as defined as clinical cure or clinical improvement [Срок оценки: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)]

Вторичные конечные точки (12)

• Microbiological cure [Срок оценки: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)]
• Microbiological cure [Срок оценки: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)]
• Microbiological cure [Срок оценки: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)]
• Microbiological cure [Срок оценки: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")]
• Clinical success as defined as clinical cure or clinical improvement [Срок оценки: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)]
• Clinical success as defined as clinical cure or clinical improvement [Срок оценки: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)]
• Clinical success as defined as clinical cure or clinical improvement [Срок оценки: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")]
• Clinical cure [Срок оценки: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)]
• Clinical cure [Срок оценки: Analysed at TOC ("Test of cure", up to 6 months after start of fosfomycin treatment)]
• Clinical cure [Срок оценки: Analysed at follow-up (within one year after start of fosfomycin treatment) (only for indication "osteomyelitis")]
• Clinical improvement [Срок оценки: Analysed at "initial response" (not later than 7 days after start of fosfomycin treatment)]
• Clinical improvement [Срок оценки: Analysed at EOT ("End of fosfomycin treatment", up to 6 months after start of fosfomycin treatment)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 14 центров

• Universitätsmedizin Charité — Berlin
• Vivantes Kliniken Neukölln — Berlin
• Städtisches Klinikum Braunschweig — Braunschweig
• Universitäts Düsseldorf; Klinik für Anästhesiologie — Düsseldorf
• Universitätsklinikum Frankfurt — Frankfurt
• Universität Hamburg-Eppendorf — Hamburg
• Universitätsklinikum Jena; Zentrum für Infektionsmedizin — Jena
• Universitätsklinikum Schleswig-Holstein — Kiel
• … и ещё 6 центров

Италия · 12 центров

• Clinical Malattie Infettive — Bari
• Azienda Ospedaliera S.Croce e Carle — Cuneo
• Ospedal Policlinico San Martino — Genova
• Ospedale L. Sacco — Milan
• Istituto Mediterraneo per i Trapianti Ismett IRCCS — Palermo
• Policlinico Paolo Giaccone — Palermo
• Policlinico Umberto I, Malattie Infettive — Rome
• Lazzaro Spallanzani — Rome
• … и ещё 4 центра

Греция · 11 центров

• General Oncology Hospital of Kifissia "Agioi Anargiroi" — Kifissia
• General Hospital of Athens "Evangelismos" — Athens
• Sotiria Thoracic Diseases Hospital of Athens — Athens
• University General Hospital "ATTIKON" — Athens
• General Hospital of Attica "KAT" — Kifissia
• General Hospital of Lamia — Lamia
• RIO Univ. Hospital, Dept of Pathology, Division of Infectious Diseases — Pátrai
• "AHEPA" University General Hospital of Thessaloniki — Thessaloniki
• … и ещё 3 центра

Великобритания · 9 центров

• Royal Bolton Hospital — Bolton
• Hull & East Yorkshire Hospitals NHS Trust — Cottingham
• Ninewells Hospital — Dundee
• Queen Elisabeth University Hospital — Glasgow
• University of Glasgow/Royal Infirmary — Glasgow
• University Hospital Crosshouse — Kilmarnock
• Chelsea & Westminster Hospial — London
• Queen Elisabeth Hospital — London
• … и ещё 1 центр

Австрия · 4 центра

• Landeskrankenhaus Hall - Tirol Kliniken — Hall in Tirol
• A.ö. Bezirkskrankenhaus — Reutte
• AKH Wien, Universitätsklinik für Innere Medizin 1 — Vienna
• Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie — Wels

Публикации

• Jarczak D, Kluge S, Kieninger M, Hagel S, Pletz MW, Zoller M, Spies C, Kintrup S, Antonitsch L, Zundel J, Del Bono V, Galfo V, Falcone M, Iasonidou C, Sarmati L, Campogiani L, Bal AM, Dimopoulos G, Vossen MG, Mastroianni CM, Bodmann KF, Herbst C, Mayer C; FORTRESS Study Group. Real-World Data on the Use of Intravenous Fosfomycin for the Treatment of Central Nervous System Infections: a Subgroup An PMID 42286374
• Bodmann KF, Hagel S, Oliva A, Kluge S, Mularoni A, Galfo V, Falcone M, Pletz MW, Lindau S, Kading N, Kielstein JT, Zoller M, Tascini C, Kintrup S, Schadler D, Spies C, De Rosa FG, Radnoti S, Bandera A, Luzzati R, Allen S, Sarmati L, Cascio A, Kapravelos N, Subudhi CPK, Dimopoulos G, Vossen MG, Bal AM, Venditti M, Mastroianni CM, Borrmann T, Mayer C. Real-World Use, Effectiveness, and Safety of Int PMID 40106180

Идентификаторы

NCT: NCT02979951 · FORTRESS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗