Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis - Full Text View

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 II

MedlinePlus related topics:

Yeast Infections

Drug Information available for:

Clotrimazole Miconazole Miconazole nitrate Tioconazole Micafungin FK 463

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

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 Saint Louis, Service D'Hematologie/Greffe de Moelle
	Paris, France, 10
	Hopital Henri Mondor, Dervice d'Hematologie Clinique
	Creteil, France, 94010
	Hopital Necker Enfants Malades, Service d"Hematologie
	Paris, France, 75015
	Hotel Dieu, Service d"Hematologie
	Nantes, France, 44093

Germany
	Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
	Wurzburg, Germany, D-97070
	LMU Munchen, Hamatopoetische Zell - Transplantation
	Munchen, Germany, D-81366
	Westpfalz Krankenhaus
	Kaiserslautern, Germany, D-67655
	Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
	Leipzig, Germany, D-04103
	Uniklinik Mainz, III. Medizinische Klinik
	Mainz, Germany, 55101
	Klinikum der Stadt, Medizinische Klinik A
	Ludwigshafen, Germany, D-67063
	Johann Wolfgang Goethe Universitat, Medizinische Klinik III
	Frankfurt, Germany, D-60590

Italy
	Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
	Milano, Italy, 20162
	Nationale Institute for Cancer Research
	Genova, Italy, I 16132

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

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