Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology

NCT ID: NCT02127788

Last Updated: 2024-10-21

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

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-03

Study Completion Date

2016-01-27

Brief Summary

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The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.

Detailed Description

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Conditions

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Antifungal Prophylaxis Haemopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Micafungin

Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin.

Micafungin

Intervention Type DRUG

intravenous

Interventions

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Micafungin

intravenous

Intervention Type DRUG

Other Intervention Names

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FK463 Mycamine

Eligibility Criteria

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Inclusion Criteria

* Adult patient with haemopathy or paediatric patients with haemopathy or solid tumor.
* Patient hospitalized in haematology, onco-haematology or onco-paediatrics unit.
* Patient initiating antifungal prophylaxis with micafungin.

Exclusion Criteria

* Patient presenting documented fungal infection.
* Patient already included in a biomedical study impacting the care management of invasive fungal infection at the time of inclusion.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma S.A.S.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical and Scientific Affairs Manager, Infectious Diseases

Role: STUDY_DIRECTOR

Astellas Pharma S.A.S.

Locations

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Site

Angers, , France

Site Status

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Angers, , France

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Béziers, , France

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Bordeaux, , France

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Brest, , France

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Clermont-Ferrand, , France

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Lille, , France

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Limoges, , France

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Marseille, , France

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Marseille, , France

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Metz, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Saint-Denis La Réunion, , France

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Vandœuvre-lès-Nancy, , France

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Countries

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France

Other Identifiers

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FR-MYC-NI-003

Identifier Type: -

Identifier Source: org_study_id

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