Invasives Aspergillosis in Acute Myeloid Leukemia

NCT ID: NCT02900430

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-12-31

Brief Summary

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

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.

Conditions

Acute Myeloid Leukemia; Invasive Aspergillosis

Study Design

• Observational Model Type: COHORT

Study Groups

Patients without antifungal prophylaxis

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

Patients without antifungal prophylaxis

Intervention Type: OTHER

Epidemiology data: clinical and biological informations collecting

Patients with antifungal prophylaxis

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

Patients without antifungal prophylaxis

Intervention Type: OTHER

Epidemiology data: clinical and biological informations collecting

Patients with antifungal prophylaxis

Intervention Type: DRUG

Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.

Interventions

Patients without antifungal prophylaxis

Epidemiology data: clinical and biological informations collecting

Intervention Type: OTHER

Patients with antifungal prophylaxis

Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.

Intervention Type: DRUG

Eligibility Criteria

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...)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaelle Guillerm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology, Brest Teaching Hospital

Lenaig Le Clech, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology, Brest Teaching Hospital

Locations

CHRU de Brest

Brest, , France

Countries

France

Other Identifiers

IA-AML

Identifier Type: -

Identifier Source: org_study_id