Invasives Aspergillosis in Acute Myeloid Leukemia

Study Overview
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Brief Summary
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Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.

Detailed Description
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Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system.

Official Title
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The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia, Invasive Aspergillosis

Intervention / Treatment
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* Other: Patients without antifungal prophylaxis
* Drug: Patients with antifungal prophylaxis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years acute myeloid leukemia intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation) Exclusion Criteria: < 18 years pregnancy no intensive chemotherapy (palliative treatment, azacytidine...)

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Patients without antifungal prophylaxis<br>Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis. | Other: Patients without antifungal prophylaxis<br>* Epidemiology data: clinical and biological informations collecting<br>|
| Patients with antifungal prophylaxis<br>Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole. | Other: Patients without antifungal prophylaxis<br>* Epidemiology data: clinical and biological informations collecting<br>Drug: Patients with antifungal prophylaxis<br>* Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of invasive aspergillosis in acute myeloid leukemia | Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency of antifungal prophylaxis by posaconazole | Comparison of two periods: 2009-2011 where patients had not antifungal prophylaxis and 2012-2015 where patients had antifungal prophylaxis by posaconazole during induction and salvage chemotherapy | 1 year | 
| Impact of antifungal prophylaxis by posaconazole about construction/demolition periods | Comparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods | 1 year |