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

Sponsor

Astellas Pharma S.A.S. (Industry)

Overall Status

Completed

CT.gov ID

NCT02127788

Collaborator

(none)

150

Enrollment

Locations

18.8

Actual Duration (Months)

8.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antifungal Prophylaxis Haemopathy	Drug: Micafungin

Study Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 3, 2014

Actual Primary Completion Date :

Jan 27, 2016

Actual Study Completion Date :

Jan 27, 2016

Arms and Interventions

Arm	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: FK463 Mycamine

Arm

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:

FK463

Mycamine

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 [Up to 3 months]
dose and administration pattern, temporary interruptions and treatment duration, oral treatment take-over
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site	Angers	France	44933
2	Site	Angers	France	49933
3	Site	Bordeaux	France	33076
4	Site	Brest	France	29609
5	Site	Béziers	France	34525
6	Site	Clermont Ferrand cedex 1	France	63003
7	Site	Lille	France	59037
8	Site	Limoges	France	37042
9	Site	Marseille	France	13273
10	Site	Marseille	France	13385
11	Site	Metz	France	57038
12	Site	Montpellier	France	34295
13	Site	Nantes	France	44093
14	Site	Paris	France	75012
15	Site	Paris	France	75019
16	Site	Saint-Denis La Réunion	France	97400
17	Site	Vandoeuvre-lès-Nancy	France	54511