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Home > "S" Clinical Trials Conditions > Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis  Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
For Condition: Candidiasis
Status: No longer recruiting
Sponsor(s): Fujisawa Healthcare, Inc. , Fujisawa GmbH
Synopsis: 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.
Details: This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 100
Location and Contact Information:
Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
Leipzig, , D-04103
Germany
Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
Milano, , 20162
Italy
Uniklinik Mainz, III. Medizinische Klinik
Mainz, , 55101
Germany
LMU Munchen, Hamatopoetische Zell - Transplantation
Munchen, , D-81366
Germany
Krankenhaus Elisabethinen Linz
Linz, , A-4010
Austria
Westpfalz Krankenhaus
Kaiserslautern, , D-67655
Germany
Hotel Dieu, Service d"Hematologie
Nantes, , 44093
France
Hopital Henri Mondor, Dervice d'Hematologie Clinique
Creteil, , 94010
France
Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
Madrid, , ES 28007
Spain
Royal Free Hospital, Dept. of Haematological Oncology
London, , NW3 2QG
United Kingdom
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
Wurzburg, , D-97070
Germany
Nationale Institute for Cancer Research
Genova, , I 16132
Italy
Klinikum der Stadt, Medizinische Klinik A
Ludwigshafen, , D-67063
Germany
Hopital Necker Enfants Malades, Service d"Hematologie
Paris, , 75015
France
Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
Huddinge, , SE141 86
Sweden
Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
Paris, , 10
France
Institute of Haematology and Blood Transfusion
Warsaw, , 00-957
Poland
Royal Marsden Hospital
Sutton Surrey, , SM2 5PT
United Kingdom
Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas
Madrid, , ES 28041
Spain
Christie Hospital NHS Trust
Manchester, , M20 4BX
United Kingdom
Johann Wolfgang Goethe Universitat, Medizinische Klinik III
Frankfurt, , D-60590
Germany
Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas
Barcelona, , 28041
Spain
Medizinische Univ.-Klinik
Graz, , A 8036
Austria
Additional Information:
Study ID Numbers: 98-0-047 (FG463-21-02);
Study Start Date: February 1999
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036179
Other Candidiasis Studies:
1. Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
2. Caspofungin for the Treatment of Non-blood Candida Infections
3. Anidulafungin versus Fluconazole in the Treatment of Candidemia
4. Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
5. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
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Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
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