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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Antifungal Prophylaxis, Haemopathy

Intervention / Treatment
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* Drug: Micafungin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Micafungin<br>Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin. | Drug: Micafungin<br>* intravenous<br>* Other names: Mycamine;|

What is the study measuring?
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Primary Outcome Measures

| 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) |  | Up to 3 months | 
| Characteristics of units | participating physicians (age, status, specialty), type of institution, location , type of unit, size of unit | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis, Haematology, Micafungin, Observational study, Invasive Fungal Infection, France