Clinical trial NCT00036179: Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Official title: An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis
Keywords: Candidemia
Anti-Fungal
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2002-05-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

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