Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology
- Registration Number
- NCT02127788
- Lead Sponsor
- Astellas Pharma S.A.S.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Micafungin Micafungin Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Description of adverse events (AE) and serious adverse events (SAE) Up to 3 months 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) 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
Trial Locations
- Locations (1)
Site
🇫🇷Vandoeuvre-lès-Nancy, France