NCT00376337

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

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
12 countries

46 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 5, 2013

Status Verified

October 1, 2011

Enrollment Period

2.3 years

First QC Date

September 13, 2006

Last Update Submit

September 4, 2013

Conditions

Invasive Aspergillosis

Keywords

Invasive AspergillosisSalvage TherapyMicafungin

Outcome Measures

Primary Outcomes (1)

  • Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.

    Weeks 3-12

Secondary Outcomes (1)

  • Overall success at end of treatment

    Weeks 3-12

Study Arms (2)

1

ACTIVE COMPARATOR

infusion for 3-12 weeks

Drug: Systemic antifungal therapy

2

EXPERIMENTAL

infusion for 3-12 weeks

Drug: Micafungin

Interventions

MicafunginDRUG

IV

Also known as: FK463
2
Systemic antifungal therapyDRUG

IV

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

Unknown Facility

Buenos Aires, Argentina

Location

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La Plata, Argentina

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Aalst, 9300, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Leuven, 3000, 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, 77520, Czechia

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Prague, 12820, Czechia

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Prague, Czechia

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Bobigny, France

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Dijon, 21034, 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, 28034, Spain

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Madrid, 28046, Spain

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Salamanca, Spain

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Seville, Spain

Location

Related Links

MeSH Terms

Interventions

Micafungin

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 14, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 5, 2013

Record last verified: 2011-10

Locations

CZ(4)BE(4)BR(10)CR(2)DE(5)HU(1)PL(3)ES(4)IT(3)AR(2)CO(3)FR(5)