IA-AML: Invasives Aspergillosis in Acute Myeloid Leukemia

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT02900430

Collaborator

(none)

246

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Invasive Aspergillosis	Other: Patients without antifungal prophylaxis Drug: Patients with antifungal prophylaxis

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.

Study Design

Study Type:

Observational

Actual Enrollment :

246 participants

Observational Model:

Cohort

Official Title:

The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Patients without antifungal prophylaxis 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 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.	Other: Patients without antifungal prophylaxis Epidemiology data: clinical and biological informations collecting Drug: Patients with antifungal prophylaxis Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.

Arm

Intervention/Treatment

Patients without antifungal prophylaxis

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

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.

Other: Patients without antifungal prophylaxis

Epidemiology data: clinical and biological informations collecting

Drug: Patients with antifungal prophylaxis

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

Outcome Measures

Primary Outcome Measures

Incidence of invasive aspergillosis in acute myeloid leukemia [1 year]
Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015

Secondary Outcome Measures

Efficiency of antifungal prophylaxis by posaconazole [1 year]
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
Impact of antifungal prophylaxis by posaconazole about construction/demolition periods [1 year]
Comparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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...)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

Principal Investigator: Gaelle Guillerm, MD, Department of Hematology, Brest Teaching Hospital
Principal Investigator: Lenaig Le Clech, MD, Department of Hematology, Brest Teaching Hospital