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

March 25, 2019 updated by: Astellas Pharma S.A.S.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospitalized, adult patients with haemopathy or paediatric patients with haemopathy or solid tumor, under antifungal prophylaxis with micafungin.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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:
  • Mycamine
  • FK463

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds ratio and 95% CI for each identified risk factors
Time Frame: Up to 3 months
Up to 3 months
Incidence of IFI, defined according to the revised EORTC/MSG criteria
Time Frame: Up to 3 months
Up to 3 months
Characteristics of patients treated with micafungin
Time Frame: Day 0 (start of prophylaxis)
Day 0 (start of prophylaxis)
Conditions of use of micafungin
Time Frame: Up to 3 months
dose and administration pattern, temporary interruptions and treatment duration, oral treatment take-over
Up to 3 months
Description of adverse events (AE) and serious adverse events (SAE)
Time Frame: Up to 3 months
Up to 3 months
Characteristics of units
Time Frame: Day 0
participating physicians (age, status, specialty), type of institution, location , type of unit, size of unit
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma S.A.S.

Investigators

  • Study Director: Medical and Scientific Affairs Manager, Infectious Diseases, Astellas Pharma S.A.S.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2014

Primary Completion (Actual)

January 27, 2016

Study Completion (Actual)

January 27, 2016

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR-MYC-NI-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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