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

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: Antifungal Prophylaxis; Haemopathy
• Intervention / Treatment: Drug: Micafungin

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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		Up to 3 months
Incidence of IFI, defined according to the revised EORTC/MSG criteria		Up to 3 months
Characteristics of patients treated with micafungin		Day 0 (start of prophylaxis)
Conditions of use of micafungin	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)		Up to 3 months
Characteristics of units	participating physicians (age, status, specialty), type of institution, location , type of unit, size of unit	Day 0

Collaborators and Investigators

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

Study record dates

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 (Estimated): May 1, 2014

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Micafungin; France; Prophylaxis; Observational study; Haematology; Invasive Fungal Infection
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Micafungin
• 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.