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Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Phase 2
Completed
Conditions
Candidiasis
Registration Number
NCT00036179
Lead Sponsor
Astellas Pharma Inc
Brief Summary

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

Detailed Description

This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (23)

Hopital Henri Mondor, Dervice d'Hematologie Clinique

🇫🇷

Creteil, France

Klinikum der Stadt, Medizinische Klinik A

🇩🇪

Ludwigshafen, Germany

Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie

🇩🇪

Wurzburg, Germany

Hotel Dieu, Service d"Hematologie

🇫🇷

Nantes, France

Medizinische Univ.-Klinik

🇦🇹

Graz, Austria

Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology

🇸🇪

Huddinge, Sweden

Royal Marsden Hospital

🇬🇧

Sutton Surrey, United Kingdom

Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas

🇪🇸

Madrid, Spain

Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas

🇪🇸

Barcelona, Spain

Royal Free Hospital, Dept. of Haematological Oncology

🇬🇧

London, United Kingdom

Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas

🇪🇸

Madrid, Spain

Johann Wolfgang Goethe Universitat, Medizinische Klinik III

🇩🇪

Frankfurt, Germany

Westpfalz Krankenhaus

🇩🇪

Kaiserslautern, Germany

Uniklinik Mainz, III. Medizinische Klinik

🇩🇪

Mainz, Germany

Christie Hospital NHS Trust

🇬🇧

Manchester, United Kingdom

LMU Munchen, Hamatopoetische Zell - Transplantation

🇩🇪

Munchen, Germany

Hopital Necker Enfants Malades, Service d"Hematologie

🇫🇷

Paris, France

Nationale Institute for Cancer Research

🇮🇹

Genova, Italy

Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie

🇩🇪

Leipzig, Germany

Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera

🇮🇹

Milano, Italy

Institute of Haematology and Blood Transfusion

🇵🇱

Warsaw, Poland

Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle

🇫🇷

Paris, France

Krankenhaus Elisabethinen Linz

🇦🇹

Linz, Austria

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