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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micafungin | Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | intravenous |
|
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized, adult patients with haemopathy or paediatric patients with haemopathy or solid tumor, under antifungal prophylaxis with micafungin.
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| Name | Affiliation | Role |
|---|---|---|
| Medical and Scientific Affairs Manager, Infectious Diseases | Astellas Pharma S.A.S. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site | Angers | 44933 | France | |||
| Site |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| 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 |
| Angers |
| 49933 |
| France |
| Site | Béziers | 34525 | France |
| Site | Bordeaux | 33076 | France |
| Site | Brest | 29609 | France |
| Site | Clermont-Ferrand | 63003 | France |
| Site | Lille | 59037 | France |
| Site | Limoges | 37042 | France |
| Site | Marseille | 13273 | France |
| Site | Marseille | 13385 | France |
| Site | Metz | 57038 | France |
| Site | Montpellier | 34295 | France |
| Site | Nantes | 44093 | France |
| Site | Paris | 75012 | France |
| Site | Paris | 75019 | France |
| Site | Saint-Denis La Réunion | 97400 | France |
| Site | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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