Invasives Aspergillosis in Acute Myeloid Leukemia (IA-AML)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Invasive Aspergillosis; Acute Myeloid Leukemia

Treatments: Other: Patients without antifungal prophylaxis; Drug: Patients with antifungal prophylaxis

Study type: Observational

Funder types: Other

Identifiers

NCT02900430

IA-AML

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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...)

Trial design

246 participants in 2 patient groups

Patients without antifungal prophylaxis

Description:

Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis.

Treatment:

Other: Patients without antifungal prophylaxis

Patients with antifungal prophylaxis

Description:

Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole.

Treatment:

Drug: Patients with antifungal prophylaxis

Other: Patients without antifungal prophylaxis