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

October 18, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma S.A.S.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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/.

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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