Micafungin Salvage Mono-therapy in Invasive Aspergillosis
NCT ID: NCT00376337
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
17 participants
INTERVENTIONAL
2006-06-30
2008-09-30
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
infusion for 3-12 weeks
Systemic antifungal therapy
IV
2
infusion for 3-12 weeks
Micafungin
IV
Interventions
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Micafungin
IV
Systemic antifungal therapy
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Buenos Aires, , Argentina
La Plata, , Argentina
Aalst, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Belo Horizonte, , Brazil
Campinas, , Brazil
Curitiba, , Brazil
Goiânia, , Brazil
Ipatinga, , Brazil
Porto Alegre, , Brazil
Ribeirão Preto, , Brazil
Rio de Janeiro, , Brazil
Santo André, , Brazil
São Paulo, , Brazil
Bogotá, , Colombia
Bucaramanga, , Colombia
Cali, , Colombia
Rijeka, , Croatia
Zagreb, , Croatia
Hradec Králové, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Bobigny, , France
Dijon, , France
Dijon, , France
Paris, , France
Pessac, , France
Berlin, , Germany
Bonn, , Germany
Munich, , Germany
Münster, , Germany
Würzburg, , Germany
Budapest, , Hungary
Monza, , Italy
Pavia, , Italy
Rozzano, , Italy
Krakow, , Poland
Lodz, , Poland
Poznan, , Poland
Madrid, , Spain
Madrid, , Spain
Salamanca, , Spain
Seville, , Spain
Countries
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Related Links
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Link to FDA website
Other Identifiers
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FG463-21-20
Identifier Type: -
Identifier Source: org_study_id