Clinical trial NCT02127788: Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antifungal Prophylaxis
Haemopathy
Keywords: Haematology
Micafungin
Observational study
Prophylaxis
Invasive Fungal Infection
France
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-05-01
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized, adult patients with haemopathy or paediatric patients with haemopathy or solid tumor, under antifungal prophylaxis with micafungin.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin
timeFrame: Up to 3 months
Secondary outcomes:
measure: Odds ratio and 95% CI for each identified risk factors
timeFrame: Up to 3 months
measure: Incidence of IFI, defined according to the revised EORTC/MSG criteria
timeFrame: Up to 3 months
measure: Characteristics of patients treated with micafungin
timeFrame: Day 0 (start of prophylaxis)
measure: Conditions of use of micafungin
timeFrame: Up to 3 months
measure: Description of adverse events (AE) and serious adverse events (SAE)
timeFrame: Up to 3 months
measure: Characteristics of units
timeFrame: Day 0
Other outcomes:
Locations:
city: Angers
country: France
facility: Site
city: Angers
country: France
facility: Site
city: Bordeaux
country: France
facility: Site
city: Brest
country: France
facility: Site
city: Béziers
country: France
facility: Site
city: Clermont Ferrand cedex 1
country: France
facility: Site
city: Lille
country: France
facility: Site
city: Limoges
country: France
facility: Site
city: Marseille
country: France
facility: Site
city: Marseille
country: France
facility: Site
city: Metz
country: France
facility: Site
city: Montpellier
country: France
facility: Site
city: Nantes
country: France
facility: Site
city: Paris
country: France
facility: Site
city: Paris
country: France
facility: Site
city: Saint-Denis La Réunion
country: France
facility: Site
city: Vandoeuvre-lès-Nancy
country: France
facility: Site
Study officials:
affiliation: Astellas Pharma S.A.S.
name: Medical and Scientific Affairs Manager, Infectious Diseases
role: STUDY_DIRECTOR
References: