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Micafungin Salvage Mono-therapy in Invasive Aspergillosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376337
Recruitment Status : Terminated (Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis)
First Posted : September 14, 2006
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: Micafungin Drug: Systemic antifungal therapy Phase 2

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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
infusion for 3-12 weeks
 Drug: Systemic antifungal therapy
IV
Experimental: 2
infusion for 3-12 weeks
 Drug: Micafungin
IV
Other Name: FK463


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall success at end of treatment [ Time Frame: Weeks 3-12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376337


Locations
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Argentina
Buenos Aires, Argentina
La Plata, Argentina
Belgium
Aalst, Belgium, 9300
Bruxelles, Belgium
Gent, Belgium
Leuven, Belgium, 3000
Brazil
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
Colombia
Bogota, Colombia
Bucaramanga, Colombia
Cali, Colombia
Croatia
Rijeka, Croatia
Zagreb, Croatia
Czech Republic
Hradec Kralove, Czech Republic
Olomouc, Czech Republic, 77520
Praha, Czech Republic, 12820
Praha, Czech Republic
France
Bobigny, France
Dijon, France, 21034
Dijon, France
Paris Cedex 10, France
Paris Cedex, France
Pessac Cedex, France
Germany
Berlin, Germany
Bonn, Germany
Munich, Germany
Munster, Germany
Wuerzburg, Germany
Hungary
Budapest, Hungary
Italy
Monza, Italy
Pavia, Italy
Rozzano, Italy
Poland
Krakow, Poland
Lodz, Poland
Poznan, Poland
Spain
Madrid, Spain, 28034
Madrid, Spain, 28046
Salamanca, Spain
Sevilla, Spain
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Central Contact Astellas Pharma Europe B.V.
More Information
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Additional Information:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00376337    
Other Study ID Numbers: FG463-21-20
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: October 2011
Keywords provided by Astellas Pharma Inc:
Invasive Aspergillosis
Salvage Therapy
Micafungin
Additional relevant MeSH terms:
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Aspergillosis
Mycoses
Bacterial Infections and Mycoses
Infections
Micafungin
Antifungal Agents
Clotrimazole
Miconazole
Anti-Infective Agents
Anti-Infective Agents, Local
 14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors