Micafungin Salvage Mono-therapy in Invasive Aspergillosis

NCT ID: NCT00376337

Last Updated: 2013-09-05

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-09-30

Brief Summary

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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

Detailed Description

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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)

Conditions

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Invasive Aspergillosis

Keywords

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Invasive Aspergillosis Salvage Therapy Micafungin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

infusion for 3-12 weeks

Group Type ACTIVE_COMPARATOR

Systemic antifungal therapy

Intervention Type DRUG

IV

2

infusion for 3-12 weeks

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

IV

Interventions

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Micafungin

IV

Intervention Type DRUG

Systemic antifungal therapy

IV

Intervention Type DRUG

Other Intervention Names

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FK463

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Buenos Aires, , Argentina

Site Status

La Plata, , Argentina

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Aalst, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Belo Horizonte, , Brazil

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Campinas, , Brazil

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Curitiba, , Brazil

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Goiânia, , Brazil

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Ipatinga, , Brazil

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Porto Alegre, , Brazil

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Ribeirão Preto, , Brazil

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Rio de Janeiro, , Brazil

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Santo André, , Brazil

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São Paulo, , Brazil

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Cali, , Colombia

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Rijeka, , Croatia

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Zagreb, , Croatia

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Bobigny, , France

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Dijon, , France

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Dijon, , France

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Paris, , France

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Pessac, , France

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Berlin, , Germany

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Bonn, , Germany

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Munich, , Germany

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Münster, , Germany

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Würzburg, , Germany

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Budapest, , Hungary

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Monza, , Italy

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Pavia, , Italy

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Rozzano, , Italy

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Krakow, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Madrid, , Spain

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Madrid, , Spain

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Salamanca, , Spain

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Seville, , Spain

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Countries

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Argentina Belgium Brazil Colombia Croatia Czechia France Germany Hungary Italy Poland Spain

Related Links

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Other Identifiers

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FG463-21-20

Identifier Type: -

Identifier Source: org_study_id