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

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: NCT02127788
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma S.A.S. )

Brief Summary:
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.

Condition or disease Intervention/treatment
Antifungal Prophylaxis Haemopathy Drug: Micafungin

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational, Longitudinal, Prospective, French, Multicentre Study Conducted on Adult and Paediatric Patients Treated With Micafungin in Prophylaxis and Followed Over a 3 Months' Period in Routine Medical Practice
Actual Study Start Date : July 3, 2014
Actual Primary Completion Date : January 27, 2016
Actual Study Completion Date : January 27, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Micafungin
Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin.
Drug: Micafungin
intravenous
Other Names:
  • FK463
  • Mycamine




Primary Outcome Measures :
  1. Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin [ Time Frame: Up to 3 months ]
    EORTC/MSG : European Organization for Research and Treatment of Cancer/ Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group


Secondary Outcome Measures :
  1. Odds ratio and 95% CI for each identified risk factors [ Time Frame: Up to 3 months ]
  2. Incidence of IFI, defined according to the revised EORTC/MSG criteria [ Time Frame: Up to 3 months ]
  3. Characteristics of patients treated with micafungin [ Time Frame: Day 0 (start of prophylaxis) ]
  4. Conditions of use of micafungin [ Time Frame: Up to 3 months ]
    dose and administration pattern, temporary interruptions and treatment duration, oral treatment take-over

  5. Description of adverse events (AE) and serious adverse events (SAE) [ Time Frame: Up to 3 months ]
  6. Characteristics of units [ Time Frame: Day 0 ]
    participating physicians (age, status, specialty), type of institution, location , type of unit, size of unit



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalized, adult patients with haemopathy or paediatric patients with haemopathy or solid tumor, under antifungal prophylaxis with micafungin.
Criteria

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.

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): NCT02127788


Locations
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France
Site
Angers, France, 44933
Site
Angers, France, 49933
Site
Bordeaux, France, 33076
Site
Brest, France, 29609
Site
Béziers, France, 34525
Site
Clermont Ferrand cedex 1, France, 63003
Site
Lille, France, 59037
Site
Limoges, France, 37042
Site
Marseille, France, 13273
Site
Marseille, France, 13385
Site
Metz, France, 57038
Site
Montpellier, France, 34295
Site
Nantes, France, 44093
Site
Paris, France, 75012
Site
Paris, France, 75019
Site
Saint-Denis La Réunion, France, 97400
Site
Vandoeuvre-lès-Nancy, France, 54511
Sponsors and Collaborators
Astellas Pharma S.A.S.
Investigators
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Study Director: Medical and Scientific Affairs Manager, Infectious Diseases Astellas Pharma S.A.S.
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Responsible Party: Astellas Pharma S.A.S.
ClinicalTrials.gov Identifier: NCT02127788    
Other Study ID Numbers: FR-MYC-NI-003
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma S.A.S. ):
Haematology
Micafungin
Observational study
Prophylaxis
Invasive Fungal Infection
France
Additional relevant MeSH terms:
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Micafungin
Antifungal Agents
Anti-Infective Agents