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NCT00036179 Clinical Trial

Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00036179
Other study ID # FG463-21-02
Secondary ID 98-0-047
Status Completed
Phase Phase 2
First received May 8, 2002
Last updated January 8, 2018
Start date February 27, 1999
Est. completion date January 27, 2002

Study information
Verified date June 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date January 27, 2002
Est. primary completion date January 27, 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FK463

Locations
Country Name City State
Austria Medizinische Univ.-Klinik Graz
Austria Krankenhaus Elisabethinen Linz Linz
France Hopital Henri Mondor, Dervice d'Hematologie Clinique Creteil
France Hotel Dieu, Service d"Hematologie Nantes
France Hopital Necker Enfants Malades, Service d"Hematologie Paris
France Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle Paris
Germany Johann Wolfgang Goethe Universitat, Medizinische Klinik III Frankfurt
Germany Westpfalz Krankenhaus Kaiserslautern
Germany Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie Leipzig
Germany Klinikum der Stadt, Medizinische Klinik A Ludwigshafen
Germany Uniklinik Mainz, III. Medizinische Klinik Mainz
Germany LMU Munchen, Hamatopoetische Zell - Transplantation Munchen
Germany Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie Wurzburg
Italy Nationale Institute for Cancer Research Genova
Italy Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera Milano
Poland Institute of Haematology and Blood Transfusion Warsaw
Spain Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas Barcelona
Spain Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas Madrid
Spain Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas Madrid
Sweden Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology Huddinge
United Kingdom Royal Free Hospital, Dept. of Haematological Oncology London
United Kingdom Christie Hospital NHS Trust Manchester
United Kingdom Royal Marsden Hospital Sutton Surrey

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

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