Skip to main content
OpenTrials
Completed

NCT Number: NCT02127788

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Antifungal Prophylaxis Bacterial Infections and Mycoses Haemopathy Infections Invasive Fungal Infections Mycoses

Sex eligibility

All sexes

Study type

Observational

Primary location

Site, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micafungin

Drug

intravenous

Other names: FK463, Mycamine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma S.A.S.

Industry

Registry information

Official study 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

Acronym: OLYMPE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 1, 2014
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.