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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02127788

Acronym

OLYMPE

Enrollment

150

Registered

2014-05-01

Start date

2014-07-03

Completion date

2016-01-27

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antifungal Prophylaxis, Haemopathy

Keywords

Haematology, Micafungin, Observational study, Prophylaxis, Invasive Fungal Infection, France

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.

Interventions

DRUGMicafungin

intravenous

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin	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

Measure	Time frame	Description
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)	—
Odds ratio and 95% CI for each identified risk factors	Up to 3 months	—
Description of adverse events (AE) and serious adverse events (SAE)	Up to 3 months	—
Characteristics of units	Day 0	participating physicians (age, status, specialty), type of institution, location , type of unit, size of unit
Conditions of use of micafungin	Up to 3 months	dose and administration pattern, temporary interruptions and treatment duration, oral treatment take-over

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026