Clinical trial NCT00036166: Study of FK463 for the Treatment of Invasive Aspergillosis
Official title: An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aspergillosis
Keywords: Aspergillus
Anti-Fungal
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2002-05-09
Enrollment: 326
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 patients with proven or probable invasive infections due to Aspergillus species.

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 proven or probable systemic infection with Aspergillus species

Exclusion Criteria

* Has abnormal liver test parameters, e.g., AST or ALT \> 10 times upper limit of normal
* Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion
* Has life-expectancy judged to be less than 5 days

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, Service 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 Krankehaus
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
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:
citation: Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.
citation: Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdiere M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.