Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Micafungin Salvage Mono-therapy in Invasive Aspergillosis

This study has been terminated.
(Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis)
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: September 13, 2006
Last updated: September 4, 2013
Last verified: October 2011
To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm

Condition Intervention Phase
Invasive Aspergillosis
Drug: Micafungin
Drug: Systemic antifungal therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response. [ Time Frame: Weeks 3-12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall success at end of treatment [ Time Frame: Weeks 3-12 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
infusion for 3-12 weeks
Drug: Systemic antifungal therapy
Experimental: 2
infusion for 3-12 weeks
Drug: Micafungin
Other Name: FK463

Detailed Description:

This is a phase II, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study.

Patients will be stratified according to the baseline infection status and the baseline neutropenic status:

  • Intolerant to previous antifungal therapy
  • Refractory to previous antifungal therapy; progression of infection
  • Refractory to previous antifungal therapy; failure to improve In case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory.
  • Neutropenic (absolute neutrophil count (ANC < 500 cells/mm3)
  • Non neutropenic (ANC >= 500 cells/mm3)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients with HSCT, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin B or voriconazole products

Exclusion Criteria:

  • Patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00376337

  Hide Study Locations
Buenos Aires, Argentina
La Plata, Argentina
Aalst, Belgium, 9300
Bruxelles, Belgium
Gent, Belgium
Leuven, Belgium, 3000
Belo Horizonte, Brazil
Campinas, Brazil
Curitiba, Brazil
Goiania, Brazil
Ipatinga, Brazil
Porto Alegre, Brazil
Ribeirao Preto, Brazil
Rio de Janeiro, Brazil
Santo Andre, Brazil
Sao Paolo, Brazil
Sao Paulo, Brazil
Bogota, Colombia
Bucaramanga, Colombia
Cali, Colombia
Rijeka, Croatia
Zagreb, Croatia
Czech Republic
Hradec Kralove, Czech Republic
Olomouc, Czech Republic, 77520
Praha, Czech Republic, 12820
Praha, Czech Republic
Bobigny, France
Dijon, France, 21034
Dijon, France
Paris Cedex 10, France
Paris Cedex, France
Pessac Cedex, France
Berlin, Germany
Bonn, Germany
Munich, Germany
Munster, Germany
Wuerzburg, Germany
Budapest, Hungary
Monza, Italy
Pavia, Italy
Rozzano, Italy
Krakow, Poland
Lodz, Poland
Poznan, Poland
Madrid, Spain, 28034
Madrid, Spain, 28046
Salamanca, Spain
Sevilla, Spain
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00376337     History of Changes
Other Study ID Numbers: FG463-21-20 
Study First Received: September 13, 2006
Last Updated: September 4, 2013
Health Authority: European Union: European Medicines Agency
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Brazil: National Committee of Ethics in Research
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ministry of Health and Social Care

Keywords provided by Astellas Pharma Inc:
Invasive Aspergillosis
Salvage Therapy

Additional relevant MeSH terms:
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents processed this record on December 09, 2016