Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036179
First received: May 8, 2002
Last updated: July 9, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Candidiasis
Drug: FK463
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Enrollment: 75
Study Start Date: February 1999
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Has Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

Exclusion Criteria

  • Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
  • Has life expectancy judged to be less than 5 days
  • De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis
  • Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036179

Locations
Austria
Medizinische Univ.-Klinik
Graz, Austria, A 8036
Krankenhaus Elisabethinen Linz
Linz, Austria, A-4010
France
Hopital Henri Mondor, Dervice d'Hematologie Clinique
Creteil, France, 94010
Hotel Dieu, Service d"Hematologie
Nantes, France, 44093
Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
Paris, France, 10
Hopital Necker Enfants Malades, Service d"Hematologie
Paris, France, 75015
Germany
Johann Wolfgang Goethe Universitat, Medizinische Klinik III
Frankfurt, Germany, D-60590
Westpfalz Krankenhaus
Kaiserslautern, Germany, D-67655
Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
Leipzig, Germany, D-04103
Klinikum der Stadt, Medizinische Klinik A
Ludwigshafen, Germany, D-67063
Uniklinik Mainz, III. Medizinische Klinik
Mainz, Germany, 55101
LMU Munchen, Hamatopoetische Zell - Transplantation
Munchen, Germany, D-81366
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
Wurzburg, Germany, D-97070
Italy
Nationale Institute for Cancer Research
Genova, Italy, I 16132
Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
Milano, Italy, 20162
Poland
Institute of Haematology and Blood Transfusion
Warsaw, Poland, 00-957
Spain
Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas
Barcelona, Spain, 28041
Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas
Madrid, Spain, ES 28041
Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
Madrid, Spain, ES 28007
Sweden
Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
Huddinge, Sweden, SE141 86
United Kingdom
Royal Free Hospital, Dept. of Haematological Oncology
London, United Kingdom, NW3 2QG
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital
Sutton Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00036179     History of Changes
Other Study ID Numbers: FG463-21-02, 98-0-047
Study First Received: May 8, 2002
Last Updated: July 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Candidemia
Anti-Fungal

Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014