Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
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Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medizinische Univ.-Klinik | Graz | Austria | A 8036 | |
2 | Krankenhaus Elisabethinen Linz | Linz | Austria | A-4010 | |
3 | Hopital Henri Mondor, Dervice d'Hematologie Clinique | Creteil | France | 94010 | |
4 | Hotel Dieu, Service d"Hematologie | Nantes | France | 44093 | |
5 | Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle | Paris | France | 10 | |
6 | Hopital Necker Enfants Malades, Service d"Hematologie | Paris | France | 75015 | |
7 | Johann Wolfgang Goethe Universitat, Medizinische Klinik III | Frankfurt | Germany | D-60590 | |
8 | Westpfalz Krankenhaus | Kaiserslautern | Germany | D-67655 | |
9 | Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie | Leipzig | Germany | D-04103 | |
10 | Klinikum der Stadt, Medizinische Klinik A | Ludwigshafen | Germany | D-67063 | |
11 | Uniklinik Mainz, III. Medizinische Klinik | Mainz | Germany | 55101 | |
12 | LMU Munchen, Hamatopoetische Zell - Transplantation | Munchen | Germany | D-81366 | |
13 | Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie | Wurzburg | Germany | D-97070 | |
14 | Nationale Institute for Cancer Research | Genova | Italy | I 16132 | |
15 | Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera | Milano | Italy | 20162 | |
16 | Institute of Haematology and Blood Transfusion | Warsaw | Poland | 00-957 | |
17 | Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas | Barcelona | Spain | 28041 | |
18 | Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas | Madrid | Spain | ES 28007 | |
19 | Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas | Madrid | Spain | ES 28041 | |
20 | Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology | Huddinge | Sweden | SE141 86 | |
21 | Royal Free Hospital, Dept. of Haematological Oncology | London | United Kingdom | NW3 2QG | |
22 | Christie Hospital NHS Trust | Manchester | United Kingdom | M20 4BX | |
23 | Royal Marsden Hospital | Sutton Surrey | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- FG463-21-02
- 98-0-047